Validation Engineer Lead
Location: Juncos, pr
Company Description
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Job Description
Key Responsibilities:
- Develop, review, and execute commissioning and qualification protocols (IQ/OQ/PQ) for downstream processing equipment.
- Coordinate FAT/SAT execution and documentation with vendors and engineering teams.
- Perform field inspections, loop checks, and functional verifications during commissioning.
- Ensure equipment is installed and operates per design specifications, user requirements, and cGMP standards.
- Support resolution of deviations and discrepancies identified during commissioning and qualification.
- Author and/or review commissioning plans, traceability matrices, risk assessments, and validation summary reports.
- Interface with validation, manufacturing, automation, and QA to ensure alignment and timely execution of CQV activities.
- Participate in change control evaluations and equipment impact assessments.
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.
Qualifications
Qualifications:
- Bachelor’s degree in engineering, biotechnology, or related life sciences discipline.
- 3–7 years of CQV experience in a GMP-regulated biotech or pharmaceutical environment.
- Strong understanding of downstream unit operations and associated automation.
- Proficient in writing and executing validation protocols and working within electronic validation systems (e.g., Valgenesis, Kneat).
- Familiarity with FDA, EMA, and ICH guidelines.
- Excellent communication and documentation skills.
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.
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