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

