In this role, the Commissioning Qualification Validation (CQV) Engineer will be responsible for a range of tasks related to the validation of equipment and facilities within the pharmaceutical industry. This position involves coordinating equipment installation, drafting and executing validation protocols, and ensuring compliance with current Good Manufacturing Practices (cGMP). The CQV Engineer will play a crucial role in maintaining the integrity of validation processes and documentation.
Project Duration: Approx. 9 Months
Starting Date: ASAP
Place of Work: Visp
Key Responsibilities
Engage in all validation activities, including:
* Facilities and utilities validation
* Validation life cycle management
* Execution of validation processes
* Technical documentation preparation
* GAP analysis and risk assessments
Deliver validation documentation, including:
* User Requirement Specifications (URS)
* Design Qualification (DQ)
* Failure Mode and Effects Analysis (FMEA)
* Risk assessments
* Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
* Protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
* Prepare and execute validation documents for equipment and systems
* Write reports on completed validation activities
* Identify efficiencies in the validation approach
* Stay updated on regulatory changes affecting validation
Perform Quality Systems activities, including:
* Document management
* Change control
* Non-conformities and CAPAs management
* Write or revise engineering-related procedures
* Support the engineering team with validation and maintenance programs
* Perform additional duties as required
Candidate Profile
* Bachelor’s Degree in a Science or Technical field
* Work Experience: 5-10 years of advanced-level experience in the pharmaceutical industry
* Exceptional technical writing abilities with a focus on thorough, accurate, and timely documentation
* Strong written and verbal communication skills, with the ability to collaborate effectively across departments
* Excellent organizational and time management skills
* Language: Proficiency in English
Job ID 41180348
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