Step into a pivotal role at a global Contract Manufacturing Organisation and help shape the future of healthcare manufacturing.
Proclinical is seeking a CQV Engineer to support validation activities for equipment, systems, and facilities within a pharmaceutical environment. This role requires proficiency in German and focuses on ensuring compliance with cGMP standards through effective validation processes. You will play a key role in drafting, executing, and documenting validation protocols while collaborating across departments to maintain quality systems.
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 prepare validation documents, including IQ, OQ, and PQ protocols.
- Execute validation protocols and document results in compliance with cGMP requirements.
- Perform risk assessments, process gap analyses, and validation lifecycle execution.
- Develop technical documentation such as URS, DQ, FMEA, FAT, SAT, and validation reports.
- Identify efficiencies in validation programs and apply lessons learned from industry practices.
- Support quality systems activities, including document management, change control, non-conformities, and CAPAs.
- Write and revise procedures related to engineering activities.
- Assist in preparing requalification and maintenance programs for equipment and facilities.
- Stay informed of regulatory changes and ensure alignment with industry standards.
- Perform other duties as assigned.
Key Skills and Requirements:
- Bachelor's degree in Science or a Technical field.
- Proficiency in German and English.
- Strong technical writing skills with the ability to document work thoroughly and accurately.
- Excellent organizational and time management abilities.
- Effective written and oral communication skills for interdepartmental collaboration.
- Familiarity with quality systems and regulatory requirements in the pharmaceutical industry.
If you are having difficulty in applying or if you have any questions, please contact Emile De Beer at e.debeer@proclinical.com.
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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