Step into a pivotal role at a global CMO and help shape the future of healthcare manufacturing.
Proclinical is looking for a Thermal Systems CQV Expert to support a project-based assignment. The role centers on implementation, certification, and testing procedures for devices and production areas, ensuring alignment with cGMP guidelines.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Coordinate the installation of equipment and draft IQ-OQ-PQ protocols.
- Execute IQ-OQ-PQ validations and document results per cGMP requirements.
- Prepare, review, and approve validation documents, including URS, DQ, FMEA, FAT, SAT, and risk assessments.
- Conduct thermal validation for process and support equipment, such as autoclaves, SIP systems, fridges, and freezers.
- Utilize tools like ellab ValSuite software, eVal Pro dataloggers, and thermocouples for validation tasks.
- Collaborate with stakeholders, including Operations, Engineering, QA, and external service providers.
- Manage qualification testing, ensuring adherence to regulatory and company standards.
- Maintain accurate documentation of test results and deviations using paper-based or digital systems like KNEAT.
- Support change control processes, CAPAs, and technical investigations.
- Participate in audits and ensure compliance with internal and external regulatory requirements.
- Train team members and maintain training records as part of the cornerstone curriculum.
- Oversee commissioning, requalification, and decommissioning of equipment, including periodic reviews.
- Contribute to process improvements and equipment optimization efforts.
Key Skills and Requirements:
- Proficiency in English and German.
- Strong technical writing skills with the ability to document work thoroughly and accurately.
- Excellent organizational and time management abilities.
- Effective communication skills for interdepartmental collaboration.
- Familiarity with GxP environments, hygiene, and gowning procedures.
- Expertise in thermal validation processes and related equipment.
- Experience with validation software and tools, such as ellab ValSuite and eVal Pro.
- Advanced knowledge of pharmaceutical industry standards and regulatory requirements.
If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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