In this role, the CQ Engineer is primarily responsible for preparing documentation in accordance with current Good Manufacturing Practices (cGMP) and all relevant internal standards related to their specific project. Additionally, they will execute the Commissioning, Qualification, and Validation (CQV) activities associated with the project's area and equipment.

Project Duration: 3 Months - extension possible (6 Months)

Starting Date: ASAP

Place of Work: Visp

Responsibilities

  • Execute activities for relevant systems in line with project procedures and guidelines
    • System Boundary development + approval
    • Prepare, execute, and approve Design Qualification, including release for IQ
    • Conduct GMP risk assessments
    • Includes vendor supervision on their testing scope and quality
    • Installation Qualification preparation, execution and approval. Includes release for OQ
    • Prepare, execute, and approve Operational Qualification, including release to OPS
  • Support Design Qualification execution for other directly impacted systems
  • Assist with documentation related to URS and FAT/SAT procedures
  • Provide support in the implementation of the Installation Commissioning process in accordance with Project procedures/guidelines
  • Possess knowledge of NH3 and other gases used in large freezers and chillers
  • Understand PSSR write-ups and system checks
  • Knowledge of HVAC and utility systems
  • Carry out shift work, where required and support other C&Q activities as needed

Candidate Profile

Minimum Requirements

  • Bachelor’s degree in Life Sciences or Engineering
  • At least 3+ years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry
  • At least 3+ years of experience in commissioning / qualification / validation of biopharmaceutical related systems and utilities
  • Proven knowledge of utilities and upstream processes
  • Experience with DeltaV (Emerson) and other control systems
  • Knowledge of cGMP and regulatory requirements
  • Able to work independently and meet deadlines
  • Languages: Fluent in English, written and verbal communication skills

Preferred Requirements

  • German is a strong advantage
  • Familiarity with COMOS/KNEAT platforms
  • Knowledge and experience in the biopharmaceutical field

Job ID 41180325