(Sr.) Validation Engineer

The position reports to the Sr. Validation Manager and is responsible for supporting commissioning, qualification, and validation (CQV) activities for GMP manufacturing facilities, utilities, equipment, computerized systems, and manufacturing processes. This position plays a key role in supporting multiple client programs across clinical and commercial manufacturing within a fast-paced CDMO environment.

Responsibilities

Execute commissioning, qualification, and validation (CQV) activities for facilities, utilities, process equipment, and manufacturing systems; Develop, review, and execute IQ, OQ, PQ protocols and validation reports; Support facility, utility, equipment, process, cleaning, and computer system validation (CSV) activities; Support technology transfer and startup activities for new client manufacturing programs; Prepare validation documentation in accordance with cGMP, FDA, EU GMP, GAMP 5, and 21 CFR Part 11 requirements; Support deviation investigations, CAPAs, change controls, and risk assessments related to validation activities; Coordinate validation activities with Manufacturing, Engineering, QA, QC, Automation, and external vendors; Participate in FAT, SAT, commissioning, equipment qualification, and facility expansion projects; Maintain validation documentation and ensure data integrity throughout the validation lifecycle; Support client audits, regulatory inspections, and internal quality audits; Identify opportunities for continuous improvement of validation processes and engineering systems; Support multiple client projects simultaneously while ensuring project timelines and quality requirements are achieved

Requirements

BS/MS in life science or related field with 9 years of experience in drug/biologics industry in GMP production environment in roles of validation/engineering; Working experience in CQV for biotechnology/pharmaceutical facility is required; Familiar with CSV in accordance to GAMP 5 and CFR Part 11; Experience in authoring of validation protocols for utility and equipment required; Familiar with GMP operational principles and practice; Ability to work across functional groups for team collaboration

Nice to have

Familiarity with process, cleaning, assay validation; Experience in aseptic fill/finish equipment qualification and aseptic process simulation (APS)

Benefits

medical, dental, and vision insurance; 401(k) retirement plan with company match that vests fully on day one; paid parental leave after three months; paid time off policy including vacation, personal, sick, floating holidays, and company holidays; flexible spending and health savings accounts; life and AD&D insurance; short- and long-term disability coverage; legal assistance; supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance; commuter benefits; well-being initiatives; peer-to-peer recognition programs