Validation Engineer

Job Responsibilities:

• Develop, review, and execute qualification protocols and supporting documentation for equipment and utilities used in sterile manufacturing operations.

• Draft technical documents including requirement specs, test protocols (IQ, OQ, PQ), traceability matrices, and risk assessments in alignment with current regulatory expectations.

• Participate in site-wide verification and commissioning activities across systems supporting aseptic processes and clean utilities.

• Oversee verification of system drawings, control panels, loop checks, and instrument calibrations.

• Coordinate testing and readiness with engineering, automation, and quality groups to meet project milestones.

• Interface with equipment suppliers during factory and site acceptance testing (FAT/SAT) to ensure technical alignment and documentation integrity.

• Support or lead deviation investigation and resolution tied to qualification activities.

• Ensure all documentation and validation packages meet inspection-ready standards (GxP, 21 CFR Part 11, Annex 15, etc.).

• Contribute to change control and ensure traceable, audit-aligned validation outcomes.

• Systems may include isolators, fill lines, lyophilizers, WFI, clean steam, nitrogen, and other classified utilities.

Qualifications:

• Bachelor’s degree in Engineering or Life Sciences (e.g., Chemical, Mechanical, or Biomedical preferred).

• 3–5 years of validation or commissioning experience in a regulated pharmaceutical or biotech setting.

• Familiarity with aseptic filling equipment, utility qualification, and GMP cleanroom operations.

• Experience executing and/or authoring protocols across the CQV lifecycle (IQ/OQ/PQ).

• Working knowledge of GAMP 5, ICH guidelines, and documentation best practices.

• Strong technical writing and cross-functional collaboration skills.

• Able to interpret technical drawings and troubleshoot equipment during startup.