Take ownership of projects, equipment, and documentation as an experienced Commissioning & Qualification Engineer. We're seeking a C&Q Engineer to support capital projects, ensuring compliance with Good Manufacturing Practice (GMP) and Quality requirements while maintaining safety and schedule adherence.
Key Responsibilities:
* Lead Commissioning & Qualification activities for Clean Utility Systems.
* Develop and execute C&Q documentation, including the Commissioning Plan, Factory Acceptance Test/Site Acceptance Test (FAT/SAT), Installation Qualification/Orientational Qualification/Performance Qualification (IQ/OQ/PQ), and Summary Reports.
* Manage daily C&Q coordination, tracking status, and addressing risks/issues.
* Ensure safe and efficient startup of equipment/utilities.
* Provide technical support for investigations and system design.
Qualifications & Experience:
* A minimum of 6 years of experience in Engineering or C&Q management, preferably in Pharma/Biotech.
* A technical degree in Engineering or a related field.
* Strong knowledge of GMP, safety, and regulatory compliance.
* Experience with risk-based commissioning and qualification strategies.
* Excellent leadership, communication, and stakeholder management skills.
* Familiarity with paperless validation systems is a plus.