The Facilities Engineer is responsible for overseeing and coordination of maintenance programs to support manufacturing, facility building operations, utilities and equipment. The position will provide oversight to HVAC and facilities’ controls & engineering reviews for capital projects. It is imperative that this individual be a self-motivated and able to interface at multiple levels within the organization. Strong verbal and written communication skills and the ability to readily adapt to changing priorities are required.

Specific duties will include, but are not limited to:

• Subject Matter Expert (SME) for all aspects of facilities’ maintenance requirements and laboratory equipment including utilities supplies, facilities controls, HVAC and electrical infrastructure.

• Review and approval of engineering documents related to any other short term or long-term projects.

• Strong knowledge of HVAC balancing, mechanical and electrical systems. Experience troubleshooting temperature, air flow, differential pressure and humidity and dehumidification problems related to the HVAC system required.

• Ensuring the return of the facility, lab equipment and/or systems to routine operations

• Experience writing technical deviations and driving investigations efficiently.
• Experience managing/executing change controls and CAPAs in a Quality Management System required.
• Troubleshooting experience on facilities/process equipment preferred.
• Knowledge of single-use technology in GMP manufacturing preferred.

Qualifications:

• Bachelor’s degree in engineering or a science related discipline preferred or equivalent combination of education and work-related experience.

• 3-5 years of pharmaceutical industry or related experience is required

• Must have experience in maintenance projects and service vendor management

• Proven experience in coordination of complicated maintenance tasks

• Knowledge and hands on experience of BMS systems

• Ensures efficiency of operation of equipment and building systems.

• Previous proficient experience with CMMS software systems

• Equipment and troubleshooting experience

• Strong understanding of applicable regulatory requirements (FDA and EMA)

• Strong understanding of industry standards for commissioning, validation, and operation of facilities and utilities for cGMP manufacturing and GXP laboratories