Validation Engineer Lead
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Job Location:
Juncos - Puerto Rico
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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:
- Bachelors degree in engineering biotechnology or related life sciences discipline.
- 37 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.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
