Lead Validation Engineer

Job Requisition: 6776

Validation Engineer (Direct Hire)

Janesville, WI

Job Requisition: 6776

Description for Validation Engineer:

The Validation Lead will support QA Therapeutics validation activities including drafting, review and execution of qualification documents. This position will support the Quality Management initiative through the creation of appropriate validation/qualification reports and presentations. This position will support Validation functions at the clinical manufacturing site, and eventually at the newly constructed commercial manufacturing site.

Responsibilities for Validation Engineer: 

  1. Establish a Master Validation Plan, review and implement all necessary standard operating procedures for plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation of critical systems and utilities.
  2. Review, plan, schedule and implement new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes.
  3. Recommend validation and qualification approaches, strategies, priorities and required resources during project planning and development phases.
  4. Drafting URS documents for major equipment purchases and support the onboarding of equipment into the cGMP system
  5. Develop and prepare protocols for process and cleaning validation, equipment commissioning and qualification (including but not limited to FAT/SAT/IOQ and PQ).
  6. Responsible for keeping the qualification/validation of the facility, equipment and processes current.
  7. Review and analyze analytical and physical data generated from executed validation/qualification activities. Write validation/qualification final reports that present, summarize and offer conclusions on the validity of the processes based on objective evidence, obtain necessary approvals.
  8. Work with Development, Manufacturing and Quality personnel to generate risk management deliverables for new projects (Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, Failure Mode and Effects Analysis).
  9. Support training activities related to qualification and validation activities through assignments in ACE (electronic Quality Management System) and on the job training (OJT).
  10. Provide status and progress reports for validation/qualification activities or projects for the Management Review Meetings.

Requirements for Validation Engineer:

  1. BS in scientific discipline or equivalent other work experience
  2. Experience in cGMP environments
  3. Experience in drafting and executing qualification documents (IQ, OQ, PQ).
  4. Previous experience with 3+ years in pharmaceutical or medical device company is preferred
  5. Ability to write procedures and protocols and review documentation


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