Sr Specialist, Technical Quality - Biotech

Marlborough Permanent
  • Join a highly disruptive and innovative Life Sciences Provider
  • Exciting opportunity to oversee qualifications at brand new facility

About Our Client

Our client is a disruptive Life Sciences provider focused on advancing the science of biopharmaceutical manufacturing and development.

Job Description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.


  • Review and ensure compliance of validation lifecycle documents and equipment acceptance tests
  • Provide quality oversight during qualification of manufacturing equipment and utilities
  • Provide technical quality input to new facility design changes
  • Facilitate and approve change controls related to equipment, facility and utilities
  • Review and approve plans and SOPs to support validated facility and equipment status
  • Provide oversight of preventive maintenance and calibration work orders and overall system health
  • Participation in communities of practice related to qualification and validation
  • Drive improvement of key performance metrics for the validation and change control systems
  • Provide technical presentations to senior management and external stakeholders

The Successful Applicant

  • Bachelor's degree of higher in Life Sciences, Chemistry, Biology, Engineering or related field
  • Minimum of 5 years of relevant biotechnology or engineering experience
  • Hands-on experience with oversight of operational functions
  • Knowledge of global GMP regulatory requirements for qualification and validation

What's on Offer

  • Very competitive base salary and benefit package with opportunity for stock options
  • Opportunity for career growth and development
  • Join a highly disruptive and innovative biopharmaceutical provider
Moriah Sweeney
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Moriah Sweeney
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