Manufacturing Equipment Qualification Engineer
Symeres
Making Molecules Matter, together with Symeres as a Manufacturing Equipment Qualification Engineer
Offer
- work for a leading transatlantic Contract Research Organisation (CRO)
- join a driven and ambitious QA team
- opportunities for learning and career development
Position
The Manufacturing Equipment Qualification Engineer is responsible for maintaining the quality and integrity of the pharmaceutical manufacturing process. This by ensuring that all manufacturing equipment and computerized systems are validated and qualified in compliance with cGMP regulations. Key tasks include reviewing and approving Computer System Validation (CSV), qualification, and calibration documents. In addition, risk assessments are evaluated and approved to ensure all potential risks are accurately identified and mitigated. Furthermore, the Manufacturing Equipment Qualification Engineer is responsible for reviewing and approving change controls, deviations, and corrective and preventive actions (CAPAs). Creating, revising, and implementing Standard Operating Procedures (SOPs) and work instructions are also part of the role. Ensuring adherence to the Quality Management System (QMS) is essential, with a continuous focus on improving this electronic documentation system through regular audits.
Profile
- hbo/wo level of education
- at least 2 years’ working experience in an Engineering role (Validation, Maintenance, Process, or similar)
- experience with Manufacturing Equipment Qualification (IQ, OQ and RRS)
- knowledge of CSV is a plus
- responsible, proactive and accurate
- excellent communication skills in English, both spoken and written
Organisation
Symeres is the leading mid-sized transatlantic contract research organisation for drug discovery and development needs. With over 700 highly educated scientists and professionals at six locations in Europe and two in the USA, they offer best-in-class solutions for drug discovery and drug development, from small- to medium-sized molecule hits. Their services span across early stage hit finding all the way to the delivery of the early clinical drug substance API. To strengthen their QA team in Weert, Symeres is looking for an experienced and enthusiastic Manufacturing Equipment Qualification Engineer.
Response
Interested? Please send your resume and motivational letter by e-mail, with reference to WS/24-234, to Anna Helsen : info@derksenderks.nl.
For further information, please call Anna Helsen at number 0645412924.
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.
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