Senior Validation Engineer

About the role

We are seeking a candidate with experience validating manufacturing equipment and PLC and computer-based control systems. The role involves performing and documenting instrument calibration and validation activities on a variety of pharmaceutical manufacturing equipment, troubleshooting and repair, and process validation such as media fills and stability studies.

Responsibilities

• Prepare, execute, and summarize validation protocols and reports.
• Demonstrate proficiency with the Kaye AVS Validator (programming, operating, setup, etc.).
• Read and understand equipment P&IDs, electrical, pneumatic, and arrangement drawings.
• Work with PC and PLC-based control systems software and hardware.
• Apply FDA and cGMP guidelines related to CVQ (Calibration, Validation, and Qualification).
• Validate and qualify utilities, distillate systems, syringe, vial and eye dropper filling machines, autoclaves, glassware and vial washers, stability chambers, drug product storage, and cleanrooms.
• Conduct process validation (PV) and stability studies.
• Solve difficult problems using rigorous logic and effective methods.
• Maintain a healthy work-life balance.

Requirements

• BS degree in Mechanical, Industrial, Automation, or Chemical Engineering and/or equivalent experience in a pharmaceutical-related discipline.
• 3 to 5 years of experience in metrology and validation of pharmaceutical manufacturing equipment.
• Experience participating in regulatory inspections and explaining/defending work.
• General knowledge of the injectable pharmaceutical industry; sterile compounding preferred.
• Experience working in cGMP environments meeting FDA, EMA, ICH guidelines, local regulations, and industry best practices.
• Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity.
• Knowledge of GMP, including international regulations and aspects of pharmaceutical GMP (e.g., quality systems, root cause analysis).
• Familiarity with 21 CFR Part 210 and 211 regulations and guidance.
• Ability to handle multiple and changing priorities under tight deadlines while remaining detail-oriented.
• Strong verbal and written communication skills.