Lead Engineering Validation
Position: Lead Engineering – Validation
Reports to the Senior Manager Engineering
Define, coordinate and guide the overall qualification & validation strategy & processes in line with project specifications in cooperation with the project team, internal & external stakeholders.
To be the link between Engineering, Qualification, Validation and QA.
- Ensure correct and state of the art Qualification/Validation approaches, to establish the Validation Plan and be accountable for all cGMP decisions taken during the Validation of the Investment project starting with the Design and ending with the establishment of the Validation Summary report.
- To ensure oversight of the qualification (IQ, OQ, PQ) and validation (PPQ, CV, PV) activities.
- Responsible for writing, reviewing and approving qualification documents (Risk Assessment, qualification protocols and reports,…).
- Responsible for coordination of qualification execution activities.
- Responsible for the implementation of the system validation guideline and SOP for the processes & equipment (Validation life-cycle process, Qualifications).
- Responsible for the implementation of adequate system validation strategy in compliance with FDA, EMA and International quality standards.
- Responsible for assuring inspection readiness – regarding system Validation
- Assistance with requirements of Equivalence Reports, Equipment Family Reports, etc.
- Master degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline.
- Experience (10 Y) in Pharmaceutical production environment, process validation, equipment validation.
- Expert in the field of qualification/validation activities & control tests, cGMP and EMA/FDA
- Understanding of good practices in biopharmaceuticals.
- Document writing experience and audit experience is important and a real asset.
- Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
- Use a risk-based approach for problem solving and prioritization of tasks.
- Blow a quality and compliance mindset through the engineering and qualification activities.
- Strong communication, organizational and influencing skills to work transversely.
- Good team player in order to succeed in the validation project.
- Has to work independently with minimal supervision and schedule tasks in time so the project can be delivered on time.
- Speaks and writes fluent English, Dutch and/or French
Prothya Biosolutions produces plasma preparations (including known products such as Cofact, Nanogam and Albuman). In addition, Prothya collects, tests and supplies blood plasma to purification and production sites worldwide. Prothya Biosolutions' mission is to provide healthcare organizations worldwide with high-quality plasma products. The company does this by creating value for partners and contributing to the health of people who depend on essential plasma proteins. Hence, Prothya's slogan: Creating Value, Sustaining Life. The company has various office and production locations in the Netherlands and Belgium and employs around 1,000 people.
Prothya Biosolutions BE is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.
In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions BE offers once a year.
We also offer an attractive holiday system exceeding the legal holidays.
Furthermore, we value mutual respect and diversity is our strength.
For each Prothya Biosolutions BE employee, from operators to the CEO, engagement means showing initiative. We expect all colleagues to contribute to achieving our annual objectives in order to take the organization towards it future challenges and successes.
Are you interested? Send your CV and covering letter.