Lead Specialist, QA Validation - Biotech

Marlborough Permanent
  • Join a highly disruptive and innovative Life Sciences Provider
  • Help drive quality and validation at brand new

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 approve equipment and utilities lifecycle documentation and procedures
  • Provide quality input to new facility design changes as new customer needs are evaluated
  • Facilitate a robust and efficient site change control process
  • Guide engineering and operations on validation approach for new processes and equipment
  • Provide site oversight of method and process validation in alignment with global quality functions
  • Deploy site data integrity program, in alignment with global Digital Quality
  • Partner with functions, including F&E, Digital, QC, MSAT, etc to continuously improve quality system metrics for validation and change control systems

The Successful Applicant

  • Bachelor's degree of higher in Life Sciences, Chemistry, Biology, Engineering or related field
  • Minimum of 10 years of pharmaceutical or biotechnology industry experience, with minimum of 5 years in a quality oversight function
  • Previous experience in engineering, validation or manufacturing operations at a biologics facility
  • Comprehensive 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
Quote job ref

Job summary

Sub Sector
Contract Type
Consultant name
Moriah Sweeney
Job Reference