CQV Engineer (Pharmaceutical Projects)
Position Overview
We are seeking an experienced CQV Engineer to join our client’s team in Carlow. As a CQV Engineer, you will play a crucial role in ensuring the successful commissioning, qualification, and validation of pharmaceutical manufacturing equipment and processes. Your expertise will contribute to maintaining compliance with industry standards and regulations.
Responsibilities
- Commissioning and Qualification (C&Q):
- Execute commissioning and validation activities for manufacturing equipment, downstream processes, and utilities.
- Prepare and review protocols for installation, operational checks, and performance qualification (IQ/OQ/PQ).
- Supervise and witness commissioning activities.
- Documentation and Compliance:
- Generate and maintain documentation related to C&Q activities throughout the equipment lifecycle.
- Ensure adherence to cGMP regulations, ISPE GAMP guidelines, and FDA guidance documents.
- Collaboration:
- Work closely with cross-functional teams, including process engineers, quality assurance, and project managers.
- Provide technical expertise during project planning and execution.
- Problem-Solving and Troubleshooting:
- Identify and resolve technical issues related to equipment performance and validation.
- Participate in risk assessments and deviation investigations.
- Continuous Improvement:
- Contribute to process optimization and efficiency enhancements.
- Stay informed about industry trends and best practices.
- Education: Bachelor’s degree in Science, Engineering, or a related field.
- Experience:
- Relevant experience in commissioning and qualifying pharmaceutical projects.
- Familiarity with regulatory requirements and industry standards.
- Skills and Attributes:
- Strong knowledge of C&Q processes and documentation.
- Ability to work in a fast-paced environment.
- Excellent problem-solving skills.
- Detail-oriented and organized.
- Effective communication and teamwork abilities.
The position is based in Carlow, Ireland.
How to Apply
Interested candidates should submit their CV and a cover letter detailing their relevant experience to our application portal.
The NRL Group connect global engineering companies with the right people to bring their projects to life. Supporting contracting companies with their energy transition plans and working with our clients to build a cleaner, greener future.
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