Senior Validation Engineer

Fagron•Wichita, KS

About The Position

The Senior Validation Engineer validates manufacturing equipment and PLC- and computer-based control systems in a pharmaceutical manufacturing environment. The role performs and documents instrument calibration and validation activities across a variety of equipment, troubleshoots and repairs equipment, and supports process validation activities such as media fills and stability studies. The engineer prepares, executes, and summarizes validation protocols and reports, and applies knowledge of equipment, control systems, and applicable pharmaceutical regulations.

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 system software and hardware.
Working knowledge of FDA and cGMP guidelines related to commissioning, validation, and qualification (CVQ).
Experience validating and qualifying utilities, distillate systems, syringe, vial and eye-dropper filling machines, autoclaves, glassware and vial washers, stability chambers, drug-product storage, and cleanrooms.
Experience with process validation and stability studies.
Experience participating in regulatory inspections and explaining or defending work.
General knowledge of the injectable pharmaceutical industry.
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, international regulations, and applicable parts of 21 CFR Parts 210 and 211.
Ability to manage multiple and changing priorities and tight deadlines while remaining detail-oriented.
Good verbal and written communication skills.

Nice To Haves

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 equipment.
Conduct or support process validation activities, including media fills and stability studies.
Validate and qualify pharmaceutical manufacturing equipment, utilities, cleanrooms, and related systems.
Participate in regulatory inspections and explain or defend validation work.