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Process Validation Engineer (M/F)

February 25th 2020

MaSTherCell is a dynamic and global Contract Development and Manufacturing Organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies to the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.

Mission Description

Key responsibilities include, but are not limited to :

  • Lead Process Validation project activities at Gosselies Site
  • Provide leadership and coordination of process validation activities
  • Support the development of Process Validation/Process Performance Qualification strategy, ensuring alignment with regulatory guidelines and industry standards
  • Lead the execution of validation projects and/or protocols and the collection of data to support completion of Process Validation activities
  • Review requirements and source process design and execution documentation for use in development of process validation documents
  • Develop/Update appropriate Validation Master Plans
  • Develop and author Validation protocols/reports
  • Author validation sections for Regulatory filings and/or provide data verification
  • Provide Process Validation oversight as part of the Change Control process
  • Participate in internal company and external health authority audits
  • Develop and mentor junior staff in validation activities
  • Keep current on the latest industrial, scientific, and regulatory trends to assist in the review and authorship of relevant sections of global regulatory filings

Candidate profile

Education & Experience :

  •  Bachelor’s degree and minimum 6 years of operations/engineering/manufacturing/quality experience
  • Experience in Project Management  
  • Minimum of 3 years of leadership experience required

Skills & Competencies:

  • 6 Years of experience in pharmaceutical or bio-pharmaceutical environment with cGMP FDA regulated operations/engineering/manufacturing/quality environment Technical understanding of pharmaceutical/biotechnology unit operations
  • Direct Validation experience with bio-pharmaceutical processes including the development of strategies, master plans, protocols, and reports
  • Proven experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or bio-pharmaceutical processes
  • Knowledge of risk-based approach to validation (FMEA) and Validation Lifecycle Approach.
  • Strong skills in communication, presentation, organization, team development, and leadership
  • Knowledge of risk-based validation methodologies, regulatory agency expectations, bio-pharmaceutical processes, project management, and business analysis
  • Ability to evaluate compliance issues and interact with regulatory inspectors
  • Knowledge and experience of the operation of Bio-pharmaceutical manufacturing processes (upstream and downstream technologies)
  • Excellent verbal and written communication skills
  • Ability to manage multiple complex tasks at one time

 

Offer

  • Full-time position (40h/week)
  • An indeterminate contract
  • The opportunity to take part in a growing dynamic biotech company
  • A human-sized working environment with a convivial atmosphere
  • A company car with fuel card

 

Contact Details

To apply for this job, please send your application via this following link MaSTherCell