Commissioning & Qualification (C&Q) Lead
- Boxmeer, North Brabant
Currently I am looking for a C&Q Lead for a pharmaceutical company in Boxmeer.
* Pharmaceutical/biotech experience, sterile manufacturing C&Q experience a plus.
* MSc or experienced BSc degree in (Bio)chemical Engineering, Biochemistry, Applied Science.
* Familiar with Last Planner methodology and pull planning.
* Excellent communication skills.
* Team player.
* Willing to work outside office hours.
* Experience in the food or (bio)pharmaceutical industry, as a C&Q Manager or senior C&Q engineer.
* Good writing and planning skills.
* Fluent in English, Dutch is a plus.
Responsibilities include, but are not limited to, the following:
Commissioning and qualification of systems is outsourced to the EPCM-CQ partner, who will be leading C&Q teams composed of C&Q Engineers. The project C&Q Lead will provide direction to the EPCM-CQ partner and will monitor the C&Q activities to ensure project requirements are met and site procedures are followed.
* C&Q management, including planning, determining C&Q deliverables and setting out C&Q related strategies for the project.
Furthermore, the C&Q Lead:
* Acts as an advocate of the C&Q Strategy and looks for opportunities to improve that strategy.
* Will familiarize him- or herself with the C&Q Safety Program and works accordingly together with the C&Q team.
* Acts as subject matter expert for C&Q related topics.
* Closely cooperates with other disciplines such as process engineers QA, QC, technical supporting groups, partners and stakeholders.
* Monitors the C&Q activities carried out by third parties.
Further to these managerial tasks, the C&Q Lead:
* Can write Validation Project Plans and project close-out Validation Project Reports.
* Assesses independently what equipment / systems should be commissioned and qualified according companies practices and procedures and reviews this with QA.
* Reviews FAT, SAT, commissioning and qualification protocols and reports.
* Is responsible for the review of turn over packages established by suppliers and partners.
Are you the new C&Q Lead? Apply online or to speak to a consultant about this project, contact Niek van Alfen via +31 (0)20 522 1588 or n.vanalfen[at]realstaffing.com