Process Validation Engineer (Fill Finish)

Position Title : Process Validation Engineer (Fill Finish)

Location : Albany, NY

Experience : 3 5 years

Industry : Biopharmaceutical / Pharmaceutical Manufacturing

Job Summary

The Process Validation Engineer (Fill Finish) supports commissioning, qualification, and validation (CQV) activities for aseptic fill-finish operations within a regulated biopharmaceutical or pharmaceutical facility. This role ensures all systems, utilities, equipment, and processes related to sterile manufacturing comply with cGMP standards, regulatory expectations, and company quality requirements.

Key Responsibilities

Commissioning & Qualification (CQ)

Develop, review, and execute commissioning and qualification protocols (IQ, OQ, PQ) for fill-finish systems, utilities, and equipment such as autoclaves, vial washers, filling lines, lyophilizers, isolators, HVAC, and clean utilities.

Participate in FAT, SAT, and site acceptance testing for new systems and equipment.

Support startup, troubleshooting, and verification during project execution and system turnover.

Ensure all CQV documentation aligns with internal standards and regulatory guidelines (FDA, EMA, ISO, ISPE).

Validation

Develop and execute process, cleaning, and sterilization validation protocols for aseptic fill-finish operations.

Perform risk assessments (FMEA, URS traceability, impact assessments) to define validation scope and priorities.

Support temperature mapping, media fills, filter integrity testing, and environmental qualification.

Align validation deliverables with project timelines and CQV strategy.

Documentation & Compliance

Author, review, and approve validation documentation (URS, DQ, IQ, OQ, PQ, summary reports, change controls).

Maintain full traceability from URS through final validation reports.

Support internal and regulatory audits, ensuring audit readiness at all times.

Follow Good Documentation Practices (GDP) and site Quality Management System (QMS) requirements.

Cross-Functional Collaboration

Work closely with Engineering, Manufacturing, QA, QC, and Project Management teams to align CQV activities with production needs.

Provide technical input and training to operations and maintenance teams during project handover and startup.

Qualifications & Experience

Bachelor's degree in Engineering, Life Sciences, or a related field (Chemical, Mechanical, Biochemical preferred).

3 5 years of experience in CQV, validation, or process engineering within aseptic fill-finish or sterile drug product manufacturing.

Solid knowledge of GMP, FDA, EMA, and ISPE standards.

Hands-on experience with aseptic equipment such as isolators, filling lines, lyophilizers, and clean utilities.

Proficiency in protocol development, data analysis, and technical report writing.

Strong analytical, organizational, and communication skills.

Experience supporting new facility startups or equipment installations is a plus.