Job Description
The Commissioning Qualification Validation engineer plays a vital role in ensuring the validation of equipment and facilities within our organization.
Key Responsibilities:
* Conduct comprehensive validation activities, encompassing facilities, utilities, validation life cycle, execution, technical documentation, process, gap analysis, risk assessment, and more.
* Develop and deliver high-quality validation documentation, including URS, DQ, FMEA, risk assessments, FAT, SAT, protocols (IQ, OQ, PQ), and other critical documents.
* Execute IQ/OQ and PQ for equipment, systems, and utilities, and prepare detailed reports on completed validation activities.
* Identify efficiencies in the validation program approach, apply lessons learned, and stay informed of industry regulatory changes to ensure optimal equipment/facility validation practices.
* Perform assigned Quality Systems activities, including document management, change control, non-conformities, and CAPAs.
* Develop and revise procedures applicable to engineering activities, ensuring alignment with best practices.
* SUPPORT THE ENGINEERING GROUP IN DEVELOPING THE VALIDATION, REQUALIFICATION, AND MAINTENANCE PROGRAM.
Requirements:
* A minimum of 5 years of experience as a CQV engineer in the pharmaceutical industry.
* Exceptional technical writing skills, with the ability to document work thoroughly, accurately, and timely.
* Excellent written and oral communication skills, enabling effective interdepartmental collaboration.