Facility Operations Engineer

Facility Operations Engineer

Central NJ

Our client – a Contract Development and Manufacturing Organization (CDMO) focused on drug discovery, development, and optimization – is seeking a highly qualified Facility Operations Engineer to join the dynamic team at their central NJ location. The selected individual will be responsible for overseeing and executing the start-up, commissioning, qualification, and validation processes of their NJ manufacturing facilities and equipment to ensure compliance with regulatory standards and internal quality requirements.

The selected applicant must be currently able to legally work in the U.S.

Responsibilities:

Commissioning and Qualification:

• Leading the timely execution of commissioning and qualification (C&Q) activities for new and existing facility systems, equipment, utilities, and related computerized systems, ensuring they meet design specifications, regulatory requirements, and User Requirement Specification (URS).
• Developing, reviewing, and approving commissioning and qualification protocols and reports.
• Coordinating with cross-functional teams, including engineering, EHS, quality assurance, maintenance, third-party vendors and operations, to ensure timely and successful execution of C&Q activities including training.

Compliance and Documentation:

• Ensuring all commissioning and qualification activities adhere to industry standards, cGMP (current Good Manufacturing Practices), and company policies.
• Maintaining accurate and comprehensive documentation of all C&Q activities, including deviations, resolutions, and change controls.
• Preparing and presenting C&Q activities and documentation for regulatory inspections and audits.
• Implementing and maintaining a new validated CMMS system for lifecycle management of equipment and reporting on key department metrics for EHS, PM/Calibration program schedule adherence and regulatory compliance.

Project Management:

• Managing and overseeing C&Q projects, including scheduling, resource allocation, and budget management.
• Developing calibration and PM procedures for CMMS system.
• Identifying and mitigating risks associated with commissioning and qualification processes.
• Collaborating with project teams to ensure seamless integration of C&Q activities with overall project timelines and deliverables.

Continuous Improvement:

• Identifying opportunities for process improvements and implementing best practices to enhance C&Q efficiency and effectiveness.
• Staying current with industry trends, regulations, and technological advancements to ensure the company remains at the forefront of facility operations and compliance.

Troubleshooting and Support:

• Providing technical support and troubleshooting for facility systems and equipment during and after commissioning and qualification.
• Addressing and resolving any issues or non-conformances that arise during and after C&Q activities.
• Assisting in tracking completion and review of maintenance and calibration activities that are related to quality events, CAPA’s, and Out of Tolerance (OOT) events.

Qualifications:

• Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related field) or equivalent experience.
• Minimum of 3-5 years of experience in facility operations, commissioning, and qualification within the CDMO or pharmaceutical industry.
• Strong knowledge of commissioning and qualification processes (ISPE C&Q 2nd edition), GMP guidelines, and regulatory requirements.
• Proficiency in using commissioning and qualification software and tools (e.g. Microsoft Office).
• Experience with HVAC, Building Automation Systems (BAS) Carrier i-Vu, Blue Mountain CMMS system, utility systems, cGMP cleanroom environments, and manufacturing equipment.
• Willingness to travel between Central NJ sites for specific project assignments.
• The ability to lift, climb, and work in outside weather conditions, around labs and chemicals, and within a plant environment.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.