Senior Pharmaceutical Validation Engineer

POSITION TITLE: Senior Pharmaceutical Validation Engineer

SUPERVISES/DIRECTSN/A

POSITION SUMMARY:

PYRAMID Laboratories, Inc. is a Bio-pharmaceutical Contract Manufacturing and Analytical Services facility located in Costa Mesa, California. The company is seeking a Senior Validation Engineer whose primary responsibilities include designing and implementing manufacturing validation programs as well as ensuring that all cGMP 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 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.
  • Develop and execute steam sterilization (autoclave) protocols, IQ/OQ/PQ, maintenance and trouble-shooting.
  • Ability to participate in vendor, client, internal and FDA audits, and generate the appropriate documentation.
  • Perform all duties and quality control/assurance/validation activities according to the applicable guidelines, i.e. FDA, cGMP, ICH etc.
  • Ability to validate, calibrate, maintain and trouble-shoot various equipment as required for all quality control/assurance activities
  • Ability to problem solve and assist in technical decision-making commensurate with the level of experience.
  • Ability to initiate problem-solving and technical decision-making commensurate with the level of experience.
  • 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.
  • Direct, plan, design, and coordinate development project activities.
  • Provide technical expertise to all project activities. Participate in short-and long-term strategic planning.
  • Perform other related duties and responsibilities as assigned.

MINIMUM QUALIFICATIONS/REQUIREMENTS:

  • Bachelor’s or Master’s degree in chemistry, biology, or related scientific discipline and a minimum of ten (10) years experience in the same or closely related cGMP environment.
  • Demonstrated competence in related manufacturing protocols and QA procedures.
  • Demonstrated ability to effectively supervise and direct personnel and to plan and direct medium to large projects.
  • Oral and written communication skill must be at a level appropriate for effective in-house communications, client contact and report preparation.

To apply for this position, please email your resume with cover letter to info@pyramidlabs.com .

2018-10-11T18:04:13+00:00