Validation Engineer

POSITION TITLE: Validation Engineer

REPORT TO: VFC Supervisor

SUPERVISES/DIRECTS: N/A

POSITION SUMMARY:

Primary responsibilities include designing and implementing manufacturing validation programs ensuring all GMP requirements are satisfied.

PRINCIPAL DUTIES:

  • 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.

MINIMUM QUALIFICATIONS/REQUIREMENTS:

  • 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 info@pyramidlabs.com .