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Lead Validation Engineer

On-site Full-time

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Experience Level

Mid to Senior

Qualifications

Qualifications:Bachelor’s degree in engineering, biotechnology, or a related life sciences field.3 to 7 years of experience in Commissioning, Qualification, and Validation (CQV) within a Good Manufacturing Practice (GMP) regulated biotech or pharmaceutical setting. In-depth knowledge of downstream unit operations and their automation. Skilled in creating and executing validation protocols, proficient with electronic validation systems (e.g., Valgenesis, Kneat). Familiarity with FDA, EMA, and ICH regulations. Exceptional communication and documentation abilities. Preferred Skills:Experience with single-use technologies (SUT) in downstream processing. Knowledge of DeltaV, Rockwell, or Siemens PLC-based automation systems. Experience working on greenfield or facility expansion projects.

About the job

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 Skids
  • Tangential Flow Filtration (TFF) systems
  • Depth filtration units
  • Centrifuges and continuous flow centrifuges
  • Virus filtration and inactivation systems
  • Bulk product hold tanks and transfer skids
  • Clean-in-place (CIP) and Steam-in-place (SIP) systems

About Validation & Engineering Group, Inc.

Validation & Engineering Group, Inc. (V&EG) stands as a premier service provider delivering tailored solutions across the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices sectors, specializing in Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other essential services.

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