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Cleaning validation engineer

Lausanne
Michael Page
Inserat online seit: 28 November
Beschreibung

Position Overview Cleaning Validation Engineer – Michael Page
Location: Ballaigues, Vaud, Switzerland
About Our Client Our client is a global leader in medicine, recognized for innovation and excellence in injectable products.
Job Description Provide expert support on cleaning validation activities (protocols, reports, investigations, strategies).
Review and approve validation documentation (URS, protocols, reports, acceptance limits).
Advise on best practices and regulatory standards (ISO, FDA, EMA, PIC/S).
Support resolution of deviations, CAPA, and compliance issues.
Design and deliver a comprehensive training program for internal teams.
Develop training materials and supervise practical implementation on-site.
Evaluate team competency and ensure full autonomy post-mission.
Conduct critical review of existing SOPs, strategies, and historical reports.
Identify opportunities for process simplification and standardization, and propose process improvements.
The Successful Applicant Degree in Chemical Engineering, Biotechnology, Pharmacy.
Minimum 5 years of experience in cleaning validation within pharma or sterile medical devices.
Strong knowledge of GMP, FDA, and EU regulatory frameworks.
Expertise in analytical techniques (TOC, HPLC, gravimetry) and risk-based approaches (MACO, PDE).
Demonstrated ability to train and coach multidisciplinary teams with pedagogical skills.
Skilled in challenging existing practices and proposing pragmatic solutions.
Fluent in English; French is an asset.
What's On Offer Work on a high-impact project shaping compliance and operational excellence.
High-impact expert role in a global organization.
Opportunity to lead strategic compliance and training initiatives.
Job Details Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Science and Health Care Provider
Industries: Staffing and Recruiting
Post date: 2 weeks ago
Contact Marion Buttay
Quote job ref: JN-112025-6886442

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