Role details

This position is now filled

Sr. Quality Engineer - Microbiology

Billerica   •   USD80,000 - USD100,000   •  Permanent

Bullet points

  • Microbiology or Chemistry background highly preferred; Clean Room Experience
  • Highly successful chemistry based pharmaceutical manufacturing company

About Our Client

Michael Page is partnering with a well established and highly successful pharmaceutical manufacturing company in the Billerica, MA area. They are currently looking to add an additional team member to their quality team with an open position for Sr. Quality Engineer. Our client is one of the top employers in the state and they are looking to add some top talent!

Job Description

The Sr. Quality Engineer will:

  • Provide direct guidance to Quality and Operations to ensure the following: compliance to all cGMPs in issues that affect products and/or their raw materials, APIs, excipients or components.
  • Work through unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on the facts.
  • Review and approve protocols, validation documents, investigations and procedures.
  • Works in cooperation with all levels of personnel in Production and the technical areas that support Production to identify root cause and determine appropriate corrective action for investigations.
  • Provides support by conducting investigations and assisting in data and information collection as required for quality events.
  • Interfaces as an SME with the FDA and other government agencies during site inspections.
  • Potential Saturday work requirements

The Successful Applicant

The successful Sr. Quality Engineer will have:

  • BS Degree in Chemistry, Microbiology, or related field
  • Minimum of 6 years of Pharmaceutical /Radio-Pharmaceutical/Bio-Pharmaceutical experiences in multiple disciplines (QC, QA, Manufacturing, Technical Support, etc.)
  • Understanding of production processes, microbiological analyses, statistical methods, quality control and quality assurance.
  • Knowledge of packaging and thermal processes.
  • Knowledge of cGMP requirements and relevant government regulations (FDA, EU, JP
  • Ability to work on potential Saturdays

What's on Offer

  • Well established and successful company
  • Top employer in the state
  • Great benefits package
  • Upward mobility within organization