Validation Engineer - Pharmaceutical Sterile Manufacturing

About Nivagen Pharmaceuticals: Nivagen Pharmaceuticals LLC is a leading global enterprise committed to improving health outcomes by delivering affordable generic prescription medications and over-the-counter products tailored for the North American market. For over ten years, we have remained dedicated to our core values of excellence, integrity, and respect for individuals. Our dedicated team tirelessly collaborates to drive innovations in manufacturing, distribution, and quality assurance, guaranteeing a comprehensive approach to healthcare. By leveraging vertical integration across the pharmaceutical supply chain, utilizing state-of-the-art technology, and maintaining a steadfast commitment to quality, we are continually working to enhance medication accessibility and affordability. We prioritize the well-being of our employees through competitive salaries, comprehensive benefits, and extensive training and development opportunities. At Nivagen, we strive to empower our workforce to foster innovation and make a positive impact in the healthcare sector. Our mission is to significantly improve lives by providing high-quality, cost-effective medications while adhering to the highest standards of integrity and excellence. Job Overview: As a Validation Engineer at Nivagen, your primary responsibility will be to ensure that our sterile pharmaceutical manufacturing processes, equipment, utilities, and systems comply with all regulatory standards, industry benchmarks, and internal specifications. This role requires independent management and support of the validation lifecycle, from installation through qualification and routine re-validation activities, ensuring strict compliance with current Good Manufacturing Practices (cGMP) and other regulatory guidelines, including FDA, EMA, and ISO standards.

About Nivagen Pharmaceuticals Nivagen Pharmaceuticals LLC develops and supplies affordable generic prescription and over-the-counter medications for the North American market. For more than a decade, the company has focused on quality, integrity, and respect, supporting its mission through vertical integration, advanced technology, and a commitment to high standards. Employees benefit from competitive pay, a strong benefits package, and ongoing training. Nivagen aims to improve healthcare access by providing reliable, cost-effective medicines. Role Overview: Sterile Manufacturing Associate The Sterile Manufacturing Associate works in Sacramento, CA and is responsible for aseptic and cleanroom manufacturing activities. This position requires strict adherence to cGMP standards, regulatory requirements, and internal standard operating procedures (SOPs). Careful attention to detail and the ability to follow established protocols help ensure the quality and safety of sterile drug products produced at Nivagen.

At Xometry (NASDAQ: XMTR), we are at the forefront of revolutionizing the manufacturing industry by connecting innovative thinkers with skilled manufacturers who can turn their visions into reality. Our digital marketplace empowers manufacturers with essential resources to expand their operations while simplifying the process for buyers from Fortune 1000 companies to access global manufacturing capabilities.We are currently in search of enthusiastic Mechanical Engineers to join our team as Manufacturing Solutions Engineers. In this pivotal role, you will be integrated within our key strategic accounts, serving as an extension of their engineering teams. This position requires a unique combination of customer interaction, technical knowledge, and operational execution. You will report to the Operations team while closely collaborating with Sales to drive growth and elevate customer satisfaction.This is an exceptional opportunity to be a part of a dynamic and expanding company leading the charge in digital manufacturing. If you are a driven Mechanical Engineer passionate about ensuring customer success and eager to make a significant impact, we invite you to apply!

Nivagen Pharmaceuticals is seeking a Microbiologist in Sacramento, CA. This position supports the company’s mission to advance pharmaceutical science through careful laboratory work and product testing. Role overview The Microbiologist will conduct microbiological analyses to help maintain the quality and safety of pharmaceutical products. This work is essential to ensure product integrity and support ongoing research efforts. Key responsibilities Perform microbiological testing and analyses on pharmaceutical products Monitor and maintain the integrity of products throughout the development process Contribute to research projects focused on improving patient care Location This role is based in Sacramento, CA 95834.

This Manufacturing Engineer Intern position at Royal Electric Company is based in Sacramento, California for Summer 2026. The internship centers on hands-on learning with the manufacturing team, blending classroom knowledge with real-world engineering and production work. Role overview Interns will work closely with engineers and production staff, contributing to daily operations and projects. The work includes both technical tasks and collaborative efforts to improve processes and support ongoing manufacturing goals. What you will do Support the team in solving engineering problems and completing technical assignments. Create and update detailed engineering drawings. Participate in process improvement initiatives alongside team members. Help build and maintain a resource library for engineering references. Design 3D models to aid in product development and documentation. Coordinate with internal teams and suppliers to ensure production and documentation needs are met. Follow safety procedures in the shop environment. Take part in quality audits, including planning, execution, reporting, and follow-up. Help ensure products are produced without defects, on schedule, and using cost-effective methods. Requirements Comfortable working in a fast-moving environment and meeting deadlines. Strong written and verbal communication skills. Ability to handle multiple tasks and see them through to completion. Keen attention to detail and strong organizational skills. Works well both independently and as part of a team. Education and experience Currently enrolled in a bachelor’s program in a relevant field, or have equivalent education and experience. Experience with 3D modeling tools. The scope of responsibilities may adjust based on each intern’s academic background, career interests, and goals. Duties may change or expand as needed during the internship. Compensation $22–$27 per hour

Join Orca Bio, a pioneering late-stage biotechnology firm dedicated to transforming the transplant landscape. We are committed to advancing cell therapies that significantly improve survival rates while minimizing risks associated with traditional allogeneic stem cell transplants. Our state-of-the-art manufacturing facility, spanning 100,000 square feet in Sacramento, CA, plays a crucial role in ensuring the reliable delivery of our high-precision investigational cell therapies. The Engineer, Manufacturing Sciences & Technology (MSAT) will focus on enhancing the efficiency and safety of our drug product manufacturing processes. This position entails lifecycle management of commercial products, process monitoring, troubleshooting, implementing and validating process improvements, and supporting investigations as well as corrective and preventive actions.

About Nivagen Pharmaceuticals:Nivagen Pharmaceuticals Inc. is a pioneering global organization committed to improving lives through the development and provision of affordable generic prescription medications and over-the-counter products tailored for the North American market. With over a decade of unwavering dedication to our core principles of excellence, integrity, and respect, we strive to lead advancements in manufacturing, distribution, and quality control, ensuring a comprehensive approach to healthcare. Through our innovative integration of the pharmaceutical supply chain and advanced technological solutions, we are consistently redefining the accessibility and affordability of medications. We prioritize the well-being of our employees by offering competitive salaries, comprehensive benefits, and extensive training and development opportunities. At Nivagen, we empower our workforce to drive innovation and create a positive impact in the healthcare landscape, as we pursue our mission to deliver high-quality, affordable medications while upholding the highest standards of integrity.

About Nivagen Pharmaceuticals LLC Nivagen Pharmaceuticals LLC develops and distributes affordable generic prescription and over-the-counter medications for the North American market. For over a decade, the company has focused on excellence, integrity, and respect. Teams at Nivagen collaborate across manufacturing, quality control, and distribution, with a commitment to improving access to essential medicines. Vertical integration and advanced technology support the company's mission to deliver high-quality products. Nivagen values its employees, offering competitive pay, comprehensive benefits, and training for professional growth. Location Sacramento, CA 95834 Role Overview: Visual Inspection and Packing Operator The Visual Inspection and Packing Operator plays a key part in maintaining product quality at Nivagen. This position involves hands-on inspection of products, operating leak testing machines, and running packing equipment to prepare shipments. The operator may participate in sterile manufacturing processes and must consistently follow company policies, standard operating procedures, regulatory guidelines, and current Good Manufacturing Practices (cGMP). Attention to detail and a strong commitment to safety and quality are essential in this role.

Join the fight against blood cancer at Orca Bio, a pioneering biotechnology company dedicated to transforming the transplant process. With over one million individuals battling blood cancer in the United States, our mission is to enhance survival rates and minimize risks through next-generation cell therapies. Our state-of-the-art, 100,000-square-foot manufacturing facility located in Sacramento, CA, plays a vital role in ensuring the reliable production of our innovative cell therapy products, ultimately restoring the lives of patients.As the Manager of Commercial Manufacturing, you will oversee the daily operations of our GMP manufacturing facility. Your responsibilities will include managing the production of cell-based therapies while ensuring compliance with regulatory guidelines, standard operating procedures (SOPs), and quality standards. You will have the opportunity to lead a dedicated team of Supervisors and support Cell Therapy Production Associates, delivering patient batches with exceptional safety, quality, and reliability.

Over one million individuals in the United States are currently battling blood cancer. While the traditional allogeneic stem cell transplant has provided hope for many, it can also carry significant risks, including fatal outcomes and severe complications such as graft versus host disease. At Orca Bio, a cutting-edge biotechnology firm, we are revolutionizing the transplant process by creating next-generation cell therapies aimed at significantly enhancing survival rates while minimizing risks. Our goal is to not only replace patients' blood and immune systems with healthy alternatives but also to restore their quality of life. We have established a state-of-the-art 100,000-square-foot manufacturing facility in Sacramento, CA, to guarantee the consistent and reliable delivery of our high-precision cell therapy products. This facility is crucial for advancing our clinical pipeline and ensuring the future commercial availability of our life-saving therapies. The Director, Commercial Manufacturing will lead our cell therapy manufacturing operations and production support functions to ensure the reliable, compliant, and timely delivery of patient-specific therapies. This role is essential in driving consistent batch execution, operational discipline, and cross-functional collaboration to meet on-time patient delivery, all while upholding the highest quality and safety standards.The Director will develop and maintain robust production systems, implement lean manufacturing principles, and spearhead continuous improvement initiatives to scale operations in a dynamic, GMP-regulated environment.

Join Orca Bio, a pioneering late-stage biotechnology firm, in our mission to revolutionize the transplant process for blood cancer patients. Our innovative cell therapies aim to significantly enhance survival rates while minimizing risks associated with traditional allogeneic stem cell transplants. Our state-of-the-art 100,000-square-foot manufacturing facility in Sacramento, CA, is at the forefront of delivering high-precision cell therapy products that have the potential to transform lives.As the Manager of Manufacturing Sciences and Technology (MSAT), you will lead a team of process engineers across multiple shifts, ensuring the smooth operation of manufacturing processes to support both clinical and commercial production. Your responsibilities will encompass overseeing daily MSAT operations, addressing deviations, conducting product impact assessments, managing change controls, implementing CAPAs, performing risk assessments, facilitating tech transfers, and driving continuous improvement initiatives. Your leadership will be crucial in upholding product quality, operational efficiency, and compliance with regulatory standards.

About Nivagen Pharmaceuticals: Nivagen Pharmaceuticals is a pioneering global organization focused on improving lives through the development and supply of affordable generic prescription medications and over-the-counter products tailored for the North American market. For over a decade, we have upheld our core values of excellence, integrity, and respect for individuals. Our dedicated team works collaboratively to drive advancements in manufacturing, distribution, and quality control, ensuring a comprehensive approach to healthcare. By leveraging vertical integration of the pharmaceutical supply chain, cutting-edge technology, and a steadfast commitment to quality, we aim to redefine medication accessibility and affordability. We prioritize the well-being of our employees by offering competitive compensation, comprehensive benefits, and extensive training and development opportunities. At Nivagen, we are committed to making a lasting impact in healthcare by delivering high-quality, affordable medications while maintaining the highest standards of integrity. Job Overview: We are looking for a skilled and dedicated Technician to join our Engineering and Maintenance team at Nivagen Pharmaceuticals. In this essential role, you will operate and maintain our HVAC, Building Management System (BMS), and Energy Management System (EMS), ensuring their safe, efficient, and reliable operation. Your contributions are vital in minimizing downtime and enhancing the overall productivity of our manufacturing operations. Key Responsibilities: Operate and maintain HVAC, BMS, EMS, and associated systems while adhering to all safety protocols and regulations. Monitor HVAC systems to identify malfunctions and schedule necessary maintenance. Conduct routine inspections and maintenance on HVAC systems to ensure optimal performance. Document and maintain daily records regarding HVAC operations, maintenance, and safety activities. Coordinate with the maintenance team to facilitate repairs and improvements. Comply with all environmental policies and regulations to ensure legal compliance. Possess knowledge related to clean room classification, Air Handling Unit (AHU) zoning, pressure balancing, and related systems.

Xometry (NASDAQ: XMTR) is revolutionizing manufacturing by connecting innovative thinkers with capable manufacturers who can turn their visions into reality. Our digital marketplace provides manufacturers with essential resources for growth while simplifying access for Fortune 1000 companies to global manufacturing capabilities.As a Supplier Quality Engineer, you will thrive in a fast-paced environment where your expertise in problem-solving and continuous improvement will be pivotal in enhancing quality metrics. This prominent role involves leading Supplier Quality initiatives while collaborating with internal departments and our supplier network to ensure the delivery of top-quality products.Your daily responsibilities will encompass a wide range of quality-focused activities with partners, guiding products from initial concept through to full-scale production within Quality Assurance. You will interact with various internal teams, including DFM Engineering, Quality, Case Management, and Partner Management, alongside a diverse array of partners specializing in CNC machining, sheet metal fabrication, additive manufacturing, and injection molding.If you excel in navigating ambiguity and are committed to establishing standardized processes, we encourage you to apply for this opportunity!

About the Role: As a Part Time/Per Diem Compounding Pharmacist at Nivagen Pharmaceuticals, you will play a crucial role in maintaining the standards of our 503B outsourcing facility, ensuring compliance with compounding regulations. Your expertise will significantly contribute to our operational goals, as you lead a compliant department dedicated to producing high-quality pharmaceutical products. Your Key Responsibilities: Collaborate with the Production Lead to meet daily compounding output targets. Develop weekly production schedules to optimize workflow and efficiency. Assign roles to technicians for effective task management. Oversee compounding activities to ensure safety and quality standards are upheld. Maintain accurate batch records and documentation. Perform various technician duties as required, including Mixer, Filler, and Assistant roles. Review customer orders to ensure accuracy and quality of products.

Nivagen Pharmaceuticals is seeking a Microbiologist Laboratory Reviewer based in Sacramento, CA. This position centers on reviewing microbiological data to help maintain the quality and safety of pharmaceutical products. Role overview The Microbiologist Laboratory Reviewer examines laboratory results and documentation, checking for accuracy and compliance with regulatory standards. This work supports the company’s commitment to producing safe and effective products. Key responsibilities Review microbiological data generated by the laboratory team Ensure all findings meet regulatory and internal quality requirements Collaborate with colleagues to address data discrepancies or questions What you bring Experience working with microbiological data and familiarity with pharmaceutical industry standards are important for this role. Strong attention to detail and the ability to work well with others will help contribute to the team’s efforts.

About Nivagen Pharmaceuticals: Nivagen Pharmaceuticals is a pioneering global entity dedicated to enhancing lives through the discovery, development, and delivery of affordable generic prescription medications and over-the-counter products in the North American market. For over a decade, we have remained committed to our core values of excellence, integrity, and respect for individuals. We prioritize investing in our workforce and foster a culture of well-being through competitive compensation, comprehensive benefits, and robust training and development resources. Position Overview: As a Warehouse Associate in our GMP Operations, you will play a crucial role in managing warehouse activities, including material handling, receipt, storage, issuance, and stock maintenance. Your meticulousness and commitment to quality will directly contribute to our operational success. Key Responsibilities: Receive, inspect, and validate incoming materials against purchase orders and quality standards. Label, store, and segregate materials accurately based on their status (e.g., quarantine, released, rejected) in designated storage areas. Pick, stage, and deliver materials to Manufacturing, QC, and other departments as per approved requests or batch records. Maintain warehouse cleanliness, organization, and inventory accuracy through routine cycle counts and adherence to 5S principles. Ensure real-time inventory accuracy utilizing ERP or inventory management systems. Assist in preparing materials for outbound shipment, including cold chain and controlled substances when applicable. Complete and maintain all required GMP documentation, including logbooks, inventory forms, and transaction records. Assist in investigating and resolving discrepancies, deviations, and inventory issues. Safely operate forklifts, pallet jacks, and other material handling equipment as trained. Comply with all applicable safety, environmental, and cGMP regulations. Participate in training, cross-functional support, and continuous improvement initiatives. Ensure FEFO (First Expiry First Out) on all material withdrawals. Check expiry and retest dates for all materials. Perform cleaning and sanitization of the warehouse as per SOP and maintain relevant logbooks. Calibrate weighing balances and other instruments following SOP.

About Nivagen Pharmaceuticals:Nivagen Pharmaceuticals is a pioneering global organization dedicated to improving lives by developing and supplying affordable generic prescription medications and over-the-counter products for the North American market. With a decade of commitment to our core values of excellence, integrity, and respect for individuals, we continue to innovate in manufacturing, distribution, and quality control. Our focus on vertical integration of the pharmaceutical supply chain, advanced technology, and a steadfast commitment to quality ensures we redefine medication accessibility and affordability. We believe in investing in our employees, offering competitive salaries, comprehensive benefits, and extensive training and development opportunities. Join us in our mission to make a significant impact in healthcare by providing high-quality, affordable medications while upholding the highest standards of integrity and excellence.Job Overview:The Compounding Pharmacist at Nivagen will lead the operations of our 503B outsourcing facility, ensuring compliance with compounding standards and regulatory requirements. This crucial role is responsible for meeting our manufacturing objectives through effective management of a fully compliant department. Key duties include maintaining facility and equipment standards, ensuring safety protocols, upholding product quality, enhancing manufacturing efficiency, and overseeing quality systems in accordance with regulations. The Compounding Pharmacist will report directly to the CEO and/or the Production Manager.

About Nivagen Pharmaceuticals: Nivagen Pharmaceuticals is a leading global organization dedicated to improving lives by discovering, developing, and providing cost-effective generic prescription drugs and over-the-counter products across North America. With over a decade of unwavering commitment to our core values of excellence, integrity, and respect for individuals, we prioritize investing in our employees and fostering a positive work culture through competitive compensation, comprehensive benefits, and ongoing training and development opportunities. Position Overview: As the Distribution Manager at Nivagen Pharmaceuticals, you will play a key role in overseeing our warehouse operations, including material handling, inventory management, and ensuring compliance with regulatory standards. Key Responsibilities: Manage daily warehouse and distribution activities to maintain efficiency, accuracy, and compliance with all regulations. Lead, organize, and train warehouse staff to optimize performance. Design and implement operational procedures for effective storage, handling, and distribution. Ensure warehouse operations align with business objectives and adhere to regulatory requirements. Interpret and apply DEA regulations in accordance with 21 CFR Parts 1300–1321. Maintain compliance with federal and state laws governing controlled substances. Uphold FDA regulations, including Current Good Manufacturing Practices (cGMP). Coordinate and manage regulatory inspections and audits conducted by DEA, FDA, and other agencies. Ensure secure storage solutions for Schedule I–II substances and restrict access to areas containing Schedule III–V substances. Implement surveillance systems to deter theft, diversion, or unauthorized access. Enforce strict security protocols related to controlled substances handling. Conduct regular and random inventory audits. Track lot numbers, batch numbers, and expiration dates effectively. Reconcile physical inventory with electronic records. Investigate and promptly resolve any discrepancies. Maintain accurate records, including DEA Form 222 and DEA Form 41.

About Nivagen Pharmaceuticals:Nivagen Pharmaceuticals is a leading global organization focused on improving lives by developing and providing affordable generic prescription medications and over-the-counter products tailored for the North American market. With over a decade of unwavering commitment to quality, integrity, and respect for individuals, our dedicated team works collaboratively to drive innovation in manufacturing, distribution, and quality assurance. Through our integrated approach to the pharmaceutical supply chain, advanced technology, and commitment to excellence, we continuously strive to enhance the accessibility and affordability of medications. We value our employees' well-being by offering competitive compensation, comprehensive benefits, and extensive training and development opportunities. At Nivagen, we empower our workforce to make a significant impact in the healthcare industry by prioritizing growth and support.Position Overview:We are currently seeking a meticulous and skilled individual to join our team as a Lab Technician - Documentation Specialist. This role is crucial for maintaining the integrity of our documentation processes and ensuring compliance with industry standards.Key Responsibilities:Develop, update, and manage analytical documents, including:Test methods and validation protocols/reportsSpecifications, STPs, SOPs, control sheets, and analytical proceduresChange controls, deviations, CAPAs, and investigation reportsEnsure alignment with cGMP, FDA, ICH, and internal quality standards.Oversee document lifecycle management utilizing electronic quality systems.Create and route documents through approval workflows in TrackWise and eInfoTree.Input, review, and maintain analytical data and workflows in StarLIMS.Collaborate effectively with QC, QA, R&D, and Regulatory teams throughout document preparation and review.Assist in internal and external audits by providing precise and compliant documentation.Ensure version control, archival, and traceability of analytical records.

About Nivagen Pharmaceuticals: Nivagen Pharmaceuticals is a leading global entity committed to enhancing lives by innovating, developing, and delivering high-quality generic prescription medications and over-the-counter products tailored for the North American market. For over a decade, we have adhered to our foundational values: excellence, integrity, and respect for individuals. Our passionate team collaborates to pioneer advancements in manufacturing, distribution, and quality control, ensuring a uniquely integrated approach to healthcare. By leveraging our vertically integrated pharmaceutical supply chain, cutting-edge technologies, and unwavering commitment to excellence, we continuously redefine the possibilities of medication accessibility and affordability. We are equally devoted to investing in our workforce, fostering a culture of well-being through competitive compensation, comprehensive benefits, and opportunities for professional growth. Core Values• People: Our workforce is our greatest asset. We prioritize understanding and addressing the needs of our team, clients, and community to cultivate an environment of support and growth.• Quality: Quality is the cornerstone of our mission, embodying our dedication to excellence in every product we offer.• Service: Our commitment to serving others is paramount. Each interaction with our patients, providers, employees, and stakeholders stems from a service-oriented mindset.• Innovation: By continuously exploring new methodologies and embracing technology, we guarantee that our solutions remain at the forefront of pharmaceutical care.