ÌìÃÀmvÌìÃÀ

Where environmental monitoring expertise meets precision, compliance, and process excellence.

ÌìÃÀmvÌìÃÀ is seeking an MSAT Expert specializing in Environmental Monitoring to join a dynamic team in Switzerland. In this role, you will act as a Subject Matter Expert (SME) in environmental qualification, manufacturing environment analytical testing, and product knowledge. You will lead Environmental Monitoring (EM) performance qualifications (PQ) and ensure compliance with European GMP, ISO13485, and 21CFR820 standards. This is a hybrid position, offering flexibility with two days of home office per week.

Responsibilities:

• Lead Environmental Monitoring (EM) performance qualification (PQ) activities.
• Facilitate effective communication between stakeholders to ensure all qualification steps align with established SOPs.
• Execute validation tasks when necessary and ensure validation documentation is clear, scientifically sound, and compliant with regulatory expectations.
• Provide comprehensive project planning and accurate budget evaluations.
• Lead technical investigations and support experiments to identify potential root causes.
• Represent Process Validation in cross-functional teams and participate in or moderate risk assessments to define validation study scopes.
• Develop and issue process validation protocols and reports, including hold time studies and leachable/extractable studies.
• Assess validation data for adherence to protocol acceptance criteria and support the investigation of deviations, defining corrective measures as needed.
• Act as a Subject Matter Expert in discrepancy records and change requests.
• Assist in developing programs and SOPs to meet current industry standards and regulatory requirements.
• Participate in regulatory inspections and customer audits.

Key Skills and Requirements:

• Advanced degree in Chemistry, Biotechnology, Life Sciences, or a related field.
• Experience in project management, preferably within MSAT, Quality, or Compliance.
• Strong knowledge of biotechnological and/or chemical manufacturing processes, validation approaches, and risk management.
• Significant experience in a GMP-regulated pharmaceutical environment, ideally within a Quality Unit.
• Proven ability to interact effectively with various stakeholders and regulatory agencies (e.g., Swissmedic, FDA).
• Familiarity with European GMP, ISO13485, and 21CFR820 standards.
  

If you are having difficulty in applying or if you have any questions, please contact Olivier Worch at o.worch@proclinical.com.

Apply Now:

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ÌìÃÀmvÌìÃÀ is a leading ÌìÃÀmvÌìÃÀ recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ÌìÃÀmvÌìÃÀ is acting as an Employment Agency in relation to this vacancy.

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