Validation Engineer (APS) (Boston)

Execute

aseptic process simulations (APS)

and support

process validation

activities, including documentation, execution, and result review. Develop and author

validation protocols

such as URS, IQ, OQ, and PQ in alignment with

GDP

and

GMP

standards. Perform

equipment and analytical instrument qualification

following regulatory and internal guidelines. Conduct

automation and software compliance assessments

to ensure adherence to

21 CFR Part 11

requirements. Coordinate cross-functional activities with engineering, quality, IT, vendors, and operations to complete

CQV (Commissioning, Qualification & Validation)

tasks. Support validation of

automated manufacturing systems

and sterile process controls. Maintain accurate, audit-ready

validation documentation

in compliance with quality system requirements. Participate in off-shift or weekend APS execution while maintaining a standard 40-hour workweek. Ensure all work aligns with applicable SOPs, regulations, and

Good Documentation Practices (GDP) .