Commissioning and Qualification (Pharma) (US)
Date Posted: September 27, 2024
Job Description
The C&Q Engineer will be responsible for the commissioning and qualification of equipment, utilities, and systems within life sciences or pharmaceutical facilities. This role involves ensuring that all systems and equipment meet regulatory and industry standards and are fully operational before being released for production. The engineer will work closely with project teams, contractors, and vendors to support compliance and ensure successful project execution.
Key Responsibilities
- Lead the commissioning and qualification activities for equipment, utilities, and systems, ensuring compliance with GMP regulations.
- Develop and review qualification protocols (IQ, OQ, PQ) and commissioning test scripts.
- Oversee the execution of commissioning and qualification activities, ensuring all systems operate per design and regulatory requirements.
- Collaborate with validation teams to ensure successful equipment and system validation.
- Provide technical support in diagnosing and resolving commissioning and qualification issues.
- Work with vendors and contractors to ensure proper equipment installation, calibration, and testing.
- Ensure all commissioning and qualification activities are performed in compliance with FDA, cGMP, and other relevant regulatory standards.
- Prepare and present detailed reports on commissioning and qualification progress to project stakeholders.
Required Qualifications and Skills
- Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or related field) or Life Sciences.
- 3-7 years of relevant experience in commissioning, qualification, and validation within life sciences, pharmaceutical, or biotechnology industries.
- Experience with equipment qualification (IQ, OQ, PQ) and utility systems (HVAC, water, gas).
- Familiarity with GMP, FDA, and industry regulatory standards.
- Proficiency in validation and qualification protocols and documentation.
- Ability to troubleshoot and resolve commissioning and qualification issues.
- Strong organizational skills to manage multiple projects and deadlines.
- Excellent verbal and written communication skills for cross-functional collaboration.
- C&Q or validation-related certifications (ISPE, CQE, or similar) are a plus.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E