Validation Engineer (m/f/d)

☞ PQE Group

View: 204

Update day: 25-03-2024

Location: Vevey Vaud VD

Category: Quality Assurance / Quality Control

Industry: Pharmaceuticals

Job type: Full-time

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Job content

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors, with more than 900 employees and 26 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE means joining a multicultural and challenging company in which you will be involved in international projects, working with colleagues from all over the world.

Due to a project that we are supporting in the area of Vevey (Switzerland), we are looking for a Validation Engineer.

Responsibilities include, but are not limited to, the following:

  • Development of qualification plans, user/technical requirements specifications, design qualification reports, test plans, requirements-testing traceability matrixes, qualification summary reports
  • Development of installation, operational and performance qualification protocols for equipment and utilities (e.g.: HVAC, Water Systems, Process Gases), according to the current internationally recognized guidelines (e.g.: ISPE, GAMP)
  • Development of thermal validation study protocols
  • Development of project validation master plans for new sites implementation including detailed Gantt charts with predecessors and resources workload evaluation (advanced knowledge of Microsoft Project requested)
  • Knowledge of the main test instruments suites (e.g.: GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments)
  • Development of risk-based assessment at process, component and functional level according to the internationally recognized methodologies (e.g.: FMEA, HACCP)
  • Development of calibration and maintenance plans and related instructions
  • Advanced knowledge of local GMPs

Requirements:

  • Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics)
  • Minimum of 3 years experience in the Pharmaceutical drug manufacturing area - Equipment and Utility validation
  • Fluent English (at least B2)
  • Integrity, strong analytical skills and attention to details
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Deadline: 09-05-2024

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