Validation Engineer II

Fagron • Canton, MA

6h

About The Position

The Validation Engineer II validates manufacturing equipment and PLC- and computer-based control systems. The role performs and documents instrument calibration and validation activities on pharmaceutical manufacturing equipment, troubleshooting and repair, and process validation activities such as media fills and stability studies. The engineer prepares, executes, and summarizes validation protocols and reports, and qualifies a range of pharmaceutical equipment, utilities, systems, and facilities.

The position requires technical knowledge of validation and metrology, applicable pharmaceutical GMP requirements, and the ability to solve difficult problems using rigorous methods. The successful candidate can manage changing priorities and tight deadlines while remaining detail-oriented and maintaining effective communication.

Requirements

• Bachelor of Science degree in Mechanical, Industrial, Automation, or Chemical Engineering, and/or equivalent experience in a pharmaceutical-related discipline.
• Three to five years of experience in metrology and validation of pharmaceutical manufacturing equipment.
• Experience validating manufacturing equipment and PLC- and computer-based control systems.
• Proficiency with the Kaye AVS Validator, including programming, operation, and setup.
• Ability to read and understand equipment P&IDs, electrical drawings, pneumatic drawings, and arrangement drawings.
• Working knowledge of PC- and PLC-based control systems, including software and hardware.
• Working knowledge of FDA and cGMP guidelines as related to CVQ.
• Experience with process validation and stability studies.
• Experience participating in regulatory inspections and explaining or defending work.
• Experience working in cGMP environments that meet FDA, EMA, and 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.
• Experience with pharmaceutical GMP topics such as quality systems and root cause analysis.
• Knowledge of GMP, including international regulations, and applicable portions of 21 CFR Parts 210 and 211 and related guidance.
• Ability to manage multiple and changing priorities and tight deadlines while remaining detail-oriented.
• Good verbal and written communication skills.

Nice To Haves

• General knowledge of the injectable pharmaceutical industry.
• Experience in sterile compounding.

Responsibilities

• Prepare, execute, and summarize validation protocols and reports.
• Perform and document instrument calibration and validation activities on pharmaceutical manufacturing equipment.
• Troubleshoot and repair manufacturing equipment and systems.
• Conduct process validation activities, including media fills and stability studies.
• Validate and qualify utilities, distillate systems, filling machines, autoclaves, washers, stability chambers, drug product storage systems, and cleanrooms.
• Participate in regulatory inspections and explain or defend validation work.

Benefits

• Competitive salary.
• 401(k) plan with company matching contribution.
• Medical insurance.
• Vision insurance.
• Dental insurance.
• Health savings account (HSA).
• Holiday and paid time off.
• Opportunities for personal and professional growth.
• Open, dynamic work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level