Validation Engineer

POSITION TITLE: Validation Engineer

REPORT TO: Validation Manager

SUPERVISES/DIRECTS: N/A

POSITION SUMMARY:

Report direct to the validation manager. Responsibilities include designing, and implementing manufacturing validation programs, and ensuring that all GMP requirements are satisfied.

PRINCIPAL DUTIES:

  • 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.

MINIMUM QUALIFICATIONS/REQUIREMENTS:

  • 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 info@pyramidlabs.com .

2017-12-11T21:43:12+00:00