Facility Operations Engineer _CDMO/Pharma

Job Title: Facility Operations Engineer

Location: Onsite, Cranbury NJ

Position Type: Full-Time

Reports To: Director, Facility Operations

Job Summary:

We are seeking a highly skilled and motivated Facility Operations Engineer with expertise in cGMP equipment commissioning and qualification to join our dynamic team in the Contract Development and Manufacturing Organization (CDMO) industry. The successful candidate will be responsible for overseeing and executing the start-up, commissioning, qualification, and validation processes of our NJ manufacturing facilities and equipment to ensure compliance with regulatory standards and internal quality requirements.

Key Responsibilities:

• Commissioning and Qualification:
• Lead 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).
• Develop, review, and approve commissioning and qualification protocols and reports.
• Coordinate 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:
• Ensure all commissioning and qualification activities adhere to industry standards, cGMP (current Good Manufacturing Practices), and company policies.
• Maintain accurate and comprehensive documentation of all C&Q activities, including deviations, resolutions, and change controls.
• Prepare and present C&Q activities and documentation for regulatory inspections and audits.
• Overall site administrator to implement and maintain a new validated CMMS system for lifecycle management of equipment and report on key department metrics for EHS, PM/Calibration program schedule adherence and regulatory compliance.
• Project Management:
• Manage and oversee C&Q projects, including scheduling, resource allocation, and budget management.
• Develop calibration and PM procedures for CMMS system.
• Identify and mitigate risks associated with commissioning and qualification processes.
• Collaborate with project teams to ensure seamless integration of C&Q activities with overall project timelines and deliverables.
• Continuous Improvement:
• Identify opportunities for process improvements and implement best practices to enhance C&Q efficiency and effectiveness.
• Stay current with industry trends, regulations, and technological advancements to ensure the company remains at the forefront of facility operations and compliance.
• Troubleshooting and Support:
• Provide technical support and troubleshooting for facility systems and equipment during and after commissioning and qualification.
• Address and resolve any issues or non-conformances that arise during and after C&Q activities.
• Assist in tracking completion and review of maintenance and calibration activities that are related to quality events, CAPA’s, and Out of Tolerance (OOT) events.
• General statement of other projects as assigned by Facility Director.

Qualifications:

• Education: Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related field) or equivalent experience.
• Experience: Minimum of 3-5 years of experience in facility operations, commissioning, and qualification within the CDMO or pharmaceutical industry.
• Technical Skills:
• 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.
• Travel between Cranbury NJ and South Plainfield NJ sites may be required based on project assignments.
• Physical Requirements: Lifting, climbing, outside weather conditions, Hot/Cold, Working around labs and chemicals, plant environment.