Senior Specialist – QA Validation

at Catalent
Location Madison, WI
Date Posted October 30, 2020
Category BioPharma
Job Type Full-time
Address 726 Heartland Trail

Description

Senior Specialist, QA Validation

The QA Validation Sr. Specialist participates in the completion of milestones associated with specific projects and supports ongoing validation efforts and quality systems responsibilities in support of the manufacture, testing, and release of formulated drug substance. This role contributes to the development of concepts and techniques specific to validation and risk management and completes tasks in a creative and effective way. The QA Validation Sr. Specialist serves as the quality contact for quality projects and continuous improvement efforts regarding Validation and Quality Risk Management.

This is a permanent, full time position.  It is a salaried role. This position is a first shift schedule- Monday- Friday from 8:00 am- 5:00 pm.

Our new, state of the art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers’ growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role:

  • Oversees, maintains, and enhances the process validation program.
  • Assists in the development of process performance qualification (PPQ) plans, including assessments of critical quality attributes and critical process parameters and determination of approach and sampling plans.
  • Drafts, reviews, executes, and approves validation protocols, reports, etc. related to process validation / PPQ.  This includes deviation reporting during execution.
  • Acts as Quality contact and primary Subject Matter Expert (SME) for Validation and Quality Risk Management.
  • Manages validation contractors as required.
  • Ensures the site Validation Master Plan remains current and aligned with corporate policies and industry standards/expectations.

The Candidate:

Education:

  • Master's Degree in technical discipline (e.g. e.g. biology, biotechnology, engineering) or related field with minimum of eight (8) years’ related experience; or
  • Bachelor's Degree in technical discipline (e.g. e.g. biology, biotechnology, engineering) or related field with minimum of ten (10) years’ related experience.

Experience:

  • Thorough knowledge of cGMP regulations related to validation including ISPE and ASTM standards.
  • Experience in aseptic processing including cell culture and protein purification is preferred.
  • Experience with 21 CFR Part 11 Compliance is preferred.
  • Experience in process validation is preferred.
  • Proven track record in validation and qualification of complex equipment / systems.

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