POSITION TITLE: Validation Engineer
REPORT TO: VFC Supervisor
Primary responsibilities include designing and implementing manufacturing validation programs ensuring all GMP requirements are satisfied.
- Primary duty of validation engineers is testing by establishing validation standards, developing testing protocols, preparing equipment, document testing results and writing final reports.
- Develop validation protocols in compliance with IQ/OQ/PQ requirements and industry guidelines as related to quality control/assurance manufacturing.
- Perform annual revalidation for steam sterilizers and dry heat sterilizers using Kaye validation system. Develop new sterilization cycles as needed.
- Perform periodic evaluation review of manufacturing and laboratory equipment.
- Maintain calibration record of equipment and calibrate equipment as needed.
- Implement Validation Master Plan for processes and equipment.
- Design and implement various protocols to validate and monitor the various quality control/assurance manufacturing activities or systems, such as water systems, air handling units, etc.
- Perform various quality control/assurance duties and initiate appropriate documentation as required.
- Assist in Change Control systems.
- Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products.
- Issue Work Orders to perform Preventive, General, and Facility Maintenance.
- Create new Standard Operating Procedures (SOPs) as needed.
- Participate in Audit activities as needed.
- Compose reports and make adjustments to equipment or processes that require improvement.
- Perform Risk-Based Analysis and validate various Part 11 Systems.
- Perform other related duties and responsibilities as assigned.
- Candidate must have a B.A./B.S. in Engineering, Chemistry, Biology, or related scientific discipline and a minimum of five (5) years experience in the same or closely related GMP environment.
- Strong oral and written communication skills commensurate for interaction with staff, vendors and clients as necessary.
- Extensive experience in steam sterilization validation.
- Demonstrated competence in related manufacturing protocols and validation procedures.
- Understanding and implementation of cGMP requirements.
- Demonstrates strong computer, organizational and project management skills.
- Good problem-solving aptitude, detail oriented, team player, multi-tasking skills.
To apply for this position, please email your resume with cover letter to firstname.lastname@example.org .