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Senior Validation Engineer

  1. Belgium, Brussels
Brussels
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36734
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Senior Validation Engineer  - Belgium - 9 Months Contract

We are looking for an experienced Senior Validation Engineer for a fantastic 9 month contract based in belgium.

You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.

This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.

Responsibilities:
  • Act as C&Q Subject Matter Expert and Compliance for PQ. Ability to provide guidance and work with project stakeholders (technical, QA, validation, QC) and suppliers in all PQ activities from strategy development to PQ protocol and acceptance criteria definition and execution and to summary report approval. to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
  • Draft PQ strategy/protocol(s) and testing rationals following approved PQ VMP, collect input from stakeholders, coordinate review and approval cycle in a timely manner.
  • Assist/ facilitate in the development of specific Quality Risk Assessment for PQ.
  • Drive PQ verification deliverables, cycle development, protocol execution, deviation investigation and resolution for problems and issues encountered during execution activities.
  • Write and coordinate approval of change controls related to technical modifications.
  • Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s). Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
Requirements:
  • Degree in relevant field, Engineering etc
  • Extensive years of hands-on, end to end experiencewith PQ phase having led and managed validation projects, including sterile manufacturing. Ideally also experience in manufacturing / manufacturing science and/or technology / technical development / quality.
  • Deep understanding and experience of all PQ verification strategy and testing.
  • Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry. Experience with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ ASTM E2500/ electronic execution.
  • Extensive knowledge and experience with Process Performance testing: Mock-up, Media Simulation, Media Fill, Engineering runs is preferred. Expert in all Biotech process, in DS/DP and ideally in Gene therapy rAAV.
  • Extensive knowledge and demonstrated experience delivering Commissioning and Qualification for single use for Pharmaceutical / Biotechnology projects including automation related aspects of equipment is preferred.
  • Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
  • Expert in reviewing and writing technical reports.
If this role is of interest to you, please apply now!
 #LI-CB1


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