Job Title: Regulatory Compliance Specialist
The role of a CQV Engineer is pivotal in ensuring the smooth operation of pharmaceutical manufacturing programs. As a CQV Engineer, you will play a crucial part in generating, executing, and approving qualification documents, as well as developing commissioning test documentation for non-direct impact systems.
Key Responsibilities:
* Generation, execution, and approval of qualification documents for facility, utility, and equipment (direct impact systems)
* Preparation of commissioning test documentation for non-direct systems
* Support clean utility tie-ins to existing systems
Requirements:
* BS degree in Engineering Science or related technical discipline
* Minimum 3 years' commissioning and qualification experience ideally in OSD or pharmaceutical environments
* Previous experience with clean utilities
* Strong technical writing skills with proven ability to produce high-quality validation documentation
* Strong interpersonal and teamwork skills with flexibility to adapt to unexpected project demands
* Demonstrated experience working within fast-paced GMP environments
This role requires an individual who can work collaboratively across engineering operations and quality teams to deliver validated systems on time. A strong understanding of cGMP and cGDP principles is essential.
As a CQV Engineer, you will be responsible for applying a risk-based approach to commissioning and qualification activities, ensuring adherence to regulatory standards. Your technical expertise, combined with excellent communication skills, will enable you to drive projects forward effectively.
If you are a motivated professional looking to make a meaningful contribution to a dynamic team, we encourage you to apply for this exciting opportunity.