Validation Engineer Lead

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:

• 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.