Senior Validation Engineer
- Belgium, Brussels
- Contract
- Commissioning, Qualification and Validation
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.
- 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.
#LI-CB1
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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