Site Engineer - The Steely Group

The Site Engineer is responsible for overseeing the maintenance, calibration, and operational readiness of equipment, utilities, and facilities supporting cGMP manufacturing and laboratory areas. This role is integral to ensure the efficient, reliable, and compliant operation of our client's facility. It combines technical expertise, strategic leadership, and team management skills, ensuring the successful development and launch of injectable drug products. The ideal candidate will bring a strong background in engineering, technical problem-solving, and cross-functional collaboration.

Responsibilities:
Facility & Equipment Maintenance & Operation:

• Manage and oversee the maintenance and calibration of manufacturing equipment, utilities (e.g., HVAC, purified water systems, compressed air), and laboratory instruments to ensure compliance with cGMP standards.
• Ensure facilities meet industry standards, regulations, and company policies, including Good Manufacturing Practices (GMP).
• Support the site’s preventive maintenance program to minimize downtime and extend the life of critical systems and equipment.
• Provide engineering expertise to troubleshoot and resolve equipment and system issues, minimizing downtime and maintaining operational efficiency. Collaborate with contractors and vendors for repairs, upgrades, and calibration services, ensuring timely and cost-effective execution of work.
• Develop and maintain technical documentation, including maintenance records, calibration logs, and validation reports, in alignment with cGMP and company standards.
• Identify and implement continuous improvement projects to enhance operations, reduce costs, and increase efficiency.

 
Quality and Regulatory Compliance:

• Coordinate and execute commissioning, qualification, and validation (CQV) activities for new and existing equipment and systems.
• Ensure compliance with local, state, and federal regulations, including OSHA, EPA, and GMP standards.
• Prepare for and participate in audits by regulatory bodies and internal inspections.
• Assist with the preparation and maintenance of facility and equipment documentation, including maintenance logs, system manuals, and regulatory compliance reports.

 
Project Management:

• Plan, design, and implement improvements or expansions, ensuring projects are completed on time, within budget, and in compliance with regulations.
• Work with vendors, contractors, and internal teams to manage capital projects, installations of new systems, and equipment maintenance and calibration activities.
• Coordinate upgrades to utilities, building systems, and equipment as necessary to support production needs.

 
Energy and Resource Management:

• Monitor and optimize energy usage across the facility to reduce costs and environmental impact.
• Evaluate and recommend improvements in energy efficiency and sustainability practices.
• Maintain effective waste management systems in line with environmental regulations.

 
Cross-functional Collaboration:

• Work closely with the Production, Quality, and EHS (Environmental, Health, and Safety) teams to ensure facility systems meet operational and safety requirements.
• Provide technical support for production processes that rely on facility systems (e.g., clean rooms, temperature-controlled storage, etc.).
• Train staff on facility systems and best practices for operating and maintaining equipment.

 
Documentation & Reporting:

• Maintain accurate records of maintenance activities, system performance, and regulatory compliance.
• Prepare reports on facility performance, energy usage, and system efficiencies for management review.
• Ensure that all necessary documentation is prepared and up to date for inspections or audits.

 

Requirements / Qualifications:

• Bachelor’s degree in Facilities Engineering, Electrical Engineering, Chemical Engineering, Mechanical Engineering, or a related field.
• 5+ years of experience in site/plant engineering or facilities management, preferably in a regulated manufacturing or biopharmaceutical environment.
• Experience with HVAC, electrical systems, clean room environments, and utility systems used in biopharmaceutical manufacturing.
• Deep understanding of regulatory requirements and novel drug development processes in the biotech space.
• Familiarity with GMP, FDA, OSHA, and other relevant regulatory standards.
• Ability to work in a fast-paced, dynamic environment with a focus on delivering results.