Senior Validation Engineer – Utilities and Facilities

Senior Validation Engineer – Utilities and FacilitiesPosition OverviewThe Senior Validation Engineer for Utilities and Facilities plays a pivotal role in ensuring the qualification and validation of essential utility systems and facility infrastructure within a GMP-regulated setting. This covers HVAC systems, water systems (including WFI and RO/DI), cleanrooms, compressed gases, and additional support utilities. The Validation Engineer ensures adherence to industry standards and regulatory mandates while collaborating with cross-functional teams to facilitate new installations, system enhancements, and operational readiness.Primary Responsibilities:1. Commissioning ActivitiesDesign and implement commissioning activities for utility systems (such as HVAC, purified water systems, clean steam, and compressed air) and facilities (including cleanrooms and environmental monitoring systems).Conduct Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and pre-qualification tests to validate system performance.Troubleshoot and resolve technical challenges during the commissioning process.2. Qualification & ValidationDraft, execute, and review qualification protocols (IQ, OQ, PQ) for utilities and facilities.Validate critical systems, including HVAC balancing, environmental monitoring, water quality assessments, and cleanroom certifications.Confirm that systems fulfill performance criteria and GMP standards.Conduct thermal mapping, pressure testing, and other essential evaluations as necessary.3. DocumentationEstablish and maintain precise and comprehensive documentation, including protocols, validation reports, and Standard Operating Procedures (SOPs).Record deviations, Corrective and Preventive Actions (CAPAs), and change controls linked to facilities and utility systems.Guarantee traceability of qualification activities in alignment with the Validation Master Plan (VMP).4. Compliance and Risk ManagementEnsure that all utility and facility qualification activities comply with global regulatory requirements (e.g., FDA, EMA, WHO).Conduct risk assessments and develop strategies to mitigate risks associated with utility and facility systems.Ensure adherence to 21 CFR Part 11, Annex 11, and relevant ISO standards.5. Lifecycle ManagementOversee requalification and periodic evaluations of utility and facility systems.Manage system upgrades, decommissioning, and retrofits while ensuring compliance with GMP regulations.Collaborate with engineering and maintenance teams to secure ongoing system reliability.6. Cross-Functional CollaborationWork in partnership with engineering, facilities, quality, and validation teams to ensure effective project delivery.Coordinate with vendors and contractors during equipment installation and qualification.Support internal and external audits and inspections.7. TrainingProvide training to facility personnel on validation processes and best practices.

Key Responsibilities:Design, assess, and implement commissioning and qualification protocols (IQ/OQ/PQ) for downstream processing equipment.Oversee Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) execution alongside vendor coordination and engineering teams.Conduct field inspections, loop checks, and functional verifications throughout the commissioning process.Guarantee that equipment is installed and functions in accordance with design specifications, user requirements, and current Good Manufacturing Practices (cGMP).Assist in addressing deviations and discrepancies found during the commissioning and qualification phases.Draft and/or review commissioning plans, traceability matrices, risk assessments, and validation summary reports.Collaborate with validation, manufacturing, automation, and Quality Assurance (QA) teams to ensure synchronized and timely completion of Commissioning, Qualification, and Validation (CQV) activities.Engage in change control assessments and equipment impact evaluations.Downstream Equipment in Scope:Chromatography SkidsTangential Flow Filtration (TFF) systemsDepth filtration unitsCentrifuges and continuous flow centrifugesVirus filtration and inactivation systemsBulk product hold tanks and transfer skidsClean-in-place (CIP) and Steam-in-place (SIP) systems

We are seeking a skilled Laboratory Validation Specialist to lead the development and execution of comprehensive Laboratory Equipment Validation. The successful candidate will be responsible for creating validation plans, conducting risk assessments, and developing critical documentation including IOQ, CSV IOQ, Traceability Matrices, Validation Reports, and both Operational and Administrative SOPs. Additionally, you will execute related validation protocols and compile documentation packages for all activities, ensuring the inclusion of original format documents, approved documents, and applicable drawings.

SUMMARYThe Senior Engineer plays a pivotal role in independently characterizing and directing process optimization strategies, alongside troubleshooting operational challenges within manufacturing, pilot plants, or capital projects. Utilizing a diverse range of advanced engineering principles, this position focuses on the design and implementation of significant system modifications and experiments. The Senior Engineer is expected to develop, organize, analyze, and present interpretations of results pertaining to complex engineering projects and operational issues.FUNCTIONSGeneral Responsibilities:1. Execute complex assignments that necessitate the development of innovative engineering techniques and procedures.2. Formulate engineering policies and procedures impacting multiple organizational units.3. Lead, coordinate, and review the work of a focused team of engineers, associates, and technicians both on an ongoing basis and for specific projects.4. Employ advanced engineering techniques and modify these techniques within the area of expertise.5. Leverage knowledge of engineering principles across a broad array of assignments in related fields.6. Serve as a recognized specialist in engineering technology within at least one domain, responsible for determining methodologies in that area.7. Apply extensive engineering knowledge in the planning and execution of projects.Design Engineering Responsibilities:1. Craft technical solutions for intricate problems, utilizing ingenuity and creativity.2. Collaborate with research, manufacturing, process development, utilities, facilities, quality assurance, and validation departments to develop requirements and recommendations for complex system and facility modifications.3. Partner with project managers to deliver design and engineering projects adhering to schedule, budget, and quality standards.4. Coordinate efforts with consultants, architects, and engineering firms in creating standard design documents.5. Develop budgets for departmental or project expenses encompassing multiple disciplines for small-scale or comprehensive projects.EDUCATIONA Doctorate degree OR a Master’s degree with three years of engineering experience OR a Bachelor’s degree in Engineering with five years of engineering experience.PREFERRED QUALIFICATIONS:• Proficient understanding of pharmaceutical and biotech processes.• Familiarity with validation processes and documentation in regulated environments.• Experience operating specialized laboratory equipment and computers as necessary.• Ability to interpret and apply Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs).• Capable of applying engineering science in production contexts.• Strong analytical, troubleshooting, and advanced problem-solving skills.• Proficient in writing technical documents and developing detailed protocols.• Self-motivated with the ability to manage multiple tasks and collaborate effectively within teams.• Adaptable to dynamic work environments.

SUMMARYAs a Senior Engineer, you will independently lead the characterization of process optimization strategies while troubleshooting operational challenges within manufacturing, pilot plants, or capital project environments. You will leverage advanced and varied engineering principles to design and implement substantial system modifications, experiments, and capital projects. Your expertise will be critical in developing, organizing, analyzing, and presenting interpretations of results related to significant operational issues or engineering projects.FUNCTIONSGeneral:1. Undertake complex or novel assignments that necessitate the development of innovative engineering techniques and procedures.2. Establish engineering policies and procedures impacting multiple organizational units.3. Oversee, coordinate, and review the work of a small team of engineers, associates, and technicians on both an ongoing and project basis.4. Utilize advanced engineering techniques and/or adapt sophisticated techniques within your area of expertise.5. Apply a broad understanding of engineering principles and practices across varied assignments in related fields.6. Serve as a recognized specialist in engineering technology within at least one domain, holding overall responsibility for determining methodologies in that area.7. Apply mature engineering knowledge in the planning and execution of projects.Other functions may be assigned.Design Engineering:1. Develop innovative technical solutions to complex challenges requiring ingenuity and creativity.2. Collaborate with research, manufacturing, process development, utilities, facilities, quality assurance, and validation departments to formulate requirements and recommendations for significant system or facility modifications.3. Partner with project managers to ensure design and engineering projects are completed within schedule, budget, and quality standards.4. Coordinate consultants, architects, and engineering firms in creating standard design documentation.5. Formulate departmental or project budgets encompassing multiple disciplines for specific project areas or the entirety of smaller projects.

We are seeking a dedicated Cleaning Validation Specialist to coordinate and oversee cleaning validation activities within our organization. This role involves preparing and executing detailed protocols and reports for cleaning development and validation processes. You will investigate deviations and discrepancies while reviewing and overseeing validation area processes.Design and develop effective cleaning procedures for new products and manufacturing equipment.Provide expert technical support for cleaning activities related to the manufacturing process.Lead and manage the cleaning validation program and related initiatives.Implement sound cleaning practices and utilize appropriate cleaning agents in new or refurbished manufacturing spaces and sampling suites.Design and support the implementation of cleaning strategies for product transfer and development projects, including providing necessary training.Conduct thorough investigations and root cause analyses of cleaning-related incidents, deviations, and out-of-specification results for cleaning procedures that are either non-validated or under development.Enhance cleaning practices, including the introduction of “clean in place” equipment.Review and approve Manufacturing Cleaning Working Instructions and Forms.Support the periodic review and assessment of cleaning validation studies.Ensure timely resolution of incidents and deviations related to cleaning validation activities.Issue Change Controls for any necessary changes to cleaning procedures.Train manufacturing and Quality Control/Quality Assurance personnel on cleaning validation documentation.

SUMMARYWorking under general supervision, you will be responsible for characterizing process optimization strategies and troubleshooting operational issues within the operations, manufacturing, pilot plant, or capital projects environments.You will apply fundamental engineering principles to design and implement system modifications, experiments, and capital projects.Your role will involve organizing, analyzing, and presenting results related to operational issues or engineering projects of moderate scope and complexity.FUNCTIONSDeliver effective solutions to a variety of technical problems that are moderate in scope and complexity.Evaluate, select, and apply standard engineering techniques and procedures under general supervision.Provide assistance for unusual problems that may arise.Complete assignments with clear and specific objectives, requiring the investigation of a limited number of variables.Initiate and finalize routine technical tasks efficiently.Operations Engineering:Act as a technical expert for equipment or systems related to troubleshooting operations. Frequently engage in daily operations as necessary to meet deadlines or resolve complex challenges.Conduct regular audits of operational performance and regulatory compliance for a moderate number of complex equipment items or systems.Collaborate with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation departments to develop requirements and recommendations for system modifications.Design Engineering:Work alongside project managers to successfully complete design, engineering, and construction projects within established schedules and budget constraints.Coordinate with consultants, architects, and engineering firms in the development of standard design documents.Request and evaluate quotes for equipment modifications or installations.Create preliminary project cost estimates and schedules.Additional responsibilities may be assigned as needed.

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