MSAT EM Expert (m/f/d)

MSAT EM Expert (M/F/D)

Tasks:

• Lead EM PQ. Ensure a proper communication between stakeholders. Ensure that all qualification steps are followed per the effective EM PQ SOP

•  This includes also when necessary execution of validation tasks. Ensure validation documentation is clear, scientifically based and in compliance with European GMP, ISO13485 expectations, 21CFR820

• Provide exhaustive planning and accurate budget evaluation for projects

• Lead technical investigations and support experiments for demonstration of potential root causes.

•  Representing the Process Validation in cross-functional teams and participating in or moderation
  of cross-functional Risk Assessments to define the scope of validation/ study activities

• Issuing process validation / study protocols and reports (incl. hold time studies and leachable &
  extractable studies) and ensuring that internal / external GMP standards and regulatory
  requirements related to process validations are adhered to in projects

•  Assessing validation data for conformance to protocol acceptance criteria and supporting the
  investigation and evaluation of deviations from the plans as well as the definition of associated
  corrective measures

• Being involved as Subject Matter Expert in the execution of Discrepancy Records and Change
  Requests

•  Assisting the department in developing programs and SOPs to meet current industry standards,
  internal and external regulatory requirements

•  Participating and support regulatory inspections and customer audits

Qualification:

• Master in Chemistry, Biotechnology, Life Sciences or related field

• Experience in project management, preferable in MSAT, Quality and Compliance

• Knowledge in biotechnological and or chemical manufacturing processes, validation approaches
  and risk management

• Significant experience in the GMP regulated pharmaceutical industry, preferable in a role within
  the Quality Unit

•  Experience in interaction with different stakeholders within an organization and with regulatory
  agencies (Swissmedic, FDA etc.) would be an advantage

Requirements: 

Start: 01.07.2026

Duration: 6 months

Capacity: 5 days per week (2 days per week remote)

Location: Visp, Switzerland