Job Title: CQV Engineer

Contract Length: 6 Months

Location/onsite requirements: Visp
 

Job Overview: The CQV Engineer will be responsible for overseeing and executing the validation of equipment, systems, and facilities in compliance with current Good Manufacturing Practices (cGMP). This role involves coordinating equipment installations, drafting and executing validation protocols (IQ/OQ/PQ), and ensuring all documentation aligns with regulatory requirements.

Key Responsibilities:

• Lead validation activities for equipment, systems, utilities, and facilities throughout the validation lifecycle.
• Draft and execute validation protocols (IQ, OQ, PQ) for equipment and systems.
• Prepare and review validation documents, including URS, DQ, FMEA, Risk Assessments, FAT, SAT, and others.
• Ensure the timely and accurate execution of IQ/OQ/PQ for equipment, systems, and utilities, and document results.
• Provide technical support to engineering teams to optimize the validation program and apply lessons learned.
• Stay updated on industry regulations and ensure validation activities meet current standards.
• Support the preparation and execution of requalification and maintenance programs for equipment and systems.
• Perform assigned Quality Systems activities, including managing Document Management Systems, Change Control, Non-Conformities, and CAPAs.
• Write and revise engineering-related procedures as required.
• Collaborate with cross-functional teams to support various validation and qualification activities.
• Assist in the continuous improvement of the validation process, identifying efficiencies where possible.

Education & Experience Requirements:

• Education: Bachelor's Degree in Science, Engineering, or a related Technical field.
• Experience: 5-10 years of advanced-level experience in the pharmaceutical industry, with a focus on equipment and facility validation.

Skills & Qualifications:

• Exceptional technical writing skills with a focus on clear, accurate, and timely documentation.
• Strong verbal and written communication skills, with the ability to collaborate effectively across departments.
• Highly organised with strong time management skills.
• In-depth knowledge of validation procedures and regulatory guidelines (cGMP).
• Ability to manage multiple tasks efficiently in a fast-paced environment.

Language Requirements: Proficiency in English (written and spoken).