CQV Engineer
- Amterdam
- 4000.00 - 6000.00
- 32-40 hours
- Project duration at least a year
- Bachelor degree
Client
Our client is a leading consulting and engineering firm in pharma, food and chemistry.
Client
Our client is a leading consulting and engineering firm in pharma, food and chemistry. They participate in interesting projects in the pharmaceutical industry. They do this by providing support to clients on challenging and varied projects. Usually with the opportunity for personal development in addition to your contribution.
Requirements
- Completed degree programme at Higher Professional Education (HBO) in engineering biotechnology, chemical technology, biochemistry, mechanical or similar;
- At least 3 years relevant work experience in the (bio)pharmaceutical industry;
- Preferably 2-3 years’ related work experience in projects or on project basis;
- Knowledge of pharmaceutical production plus equipment and the cGMP/EU/FDA requirements including latest developments relating to commissioning, qualification or validation;
- Knowledge about preparing, reading, checking and improving technical specifications (URS, functional specifications (FS), detailed technical specifications, technical drawings, P&IDs and PFDs);
- Experience in writing VMP, URS, DQIQOQPQ's and reports;
- Experience in preparing and supporting Risk Assessment and Design Reviews;
- Good communication skills;
- Proficient in Dutch and English. Fluent Afrikaans is sufficient as wel;
What do you get?
- Pension entitlement (15.9% employer contribution, 7.5% employee contribution)
- Collective WGA / WIA insurance
- NBBU collective labour agreement through equal remuneration
- 25 holidays days
- 8% holiday allowance
- 100% payment in case of illness in the first year
- Travel allowance per kilometer or through public transport
Duties
- Provide quality oversight role on CQV/Engineering related projects.
- Support new system introduction by serving as a technical resource and providing technical expertise.
- Provide risk-based validation strategy/approach for site impacting projects and changes ensuring Site Validation Master Plan is followed.
- Review and approve all CQV initial, change based validation and periodic revalidation deliverables.
- Develops strategies to implement changes to processes.
- Contributes to organization processes across functions and interacts effectively with the other team members.
- With guidance, prioritizes own work to ensure conformance to departmental goals.
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
- Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- May assist with compliance audits as required.
- Normally receives no instruction on routine work, general instructions on new assignments.
