POSITION TITLE: Validation Engineer
REPORT TO: Validation Manager
Report direct to the validation manager. Responsibilities include designing, and implementing manufacturing validation programs, and ensuring that all GMP requirements are satisfied.
- Develop validation protocols in compliance with IQ/OQ/PQ requirements and industry guidelines as related to quality control/assurance manufacturing activities.
- Design and implement various protocols to validate and monitor the various quality control/assurance manufacturing activities or systems, such as, WFI, air handling, etc., in compliance with cGMP and industry guidelines.
- Ability to validate, calibrate, maintain and trouble-shoot various equipment as required for all quality control/assurance activities.
- Perform various quality control/assurance duties and initiate appropriate documentation as required.
- Written and oral skills at a level commensurate for interaction with staff, vendors and clients as necessary.
- Perform Risk-Based Analysis and validate various Part 11 Systems.
- Implement and validate various control systems.
- Plan, design, and coordinate development project activities.
- Perform other related duties and responsibilities as assigned.
- Bachelor’s or Master’s degree in engineering, chemistry, biology, or related scientific discipline and a minimum of three (3) years experience in the same or closely related GMP environment.
- Demonstrated competence in related Mfg. protocols and validation procedures.
- Oral and written communication skill must be at a level appropriate for effective in-house communications and report preparation.
To apply for this position, please email your resume with cover letter to firstname.lastname@example.org .