GMP Facilities engineer

Job Title : GMP Facilities engineer

Location : Bothell, WA

Experience : 5+ Years

Type : 12+ months contract

Position Summary

We are seeking an experienced GMP Facilities engineer to support maintenance and reliability activities for QC Laboratories, Manufacturing Facilities, and GMP Warehouses. The ideal candidate will ensure smooth operation of all utilities, equipment, and systems that support reliable medicine production within a regulated environment.

Key Responsibilities

Safety & Compliance

Prioritize safety at all times, ensuring adherence to all site and regulatory safety protocols.

Ensure all utilities, facilities, and systems meet OSHA, ISPE, and FDA standards.

Manage CAPAs, deviations, and change controls related to utilities and facilities systems.

Technical & Maintenance Expertise

Oversee operation, maintenance, and troubleshooting of critical utility systems, including :

HVAC systems

Air compressors and pumps

Chillers and water systems (e.g., WFI, RO, process water)

Electrical systems and generators

Fire protection systems

Automation systems and variable frequency drives (VFDs)

Use CMMS (e.g., BMRAM or equivalent) to manage work orders and maintenance activities.

Develop and execute preventive and corrective maintenance plans.

Conduct root cause analysis (RCA) to resolve equipment and system failures.

Project & Vendor Coordination

Lead small capital and utility-related projects, including shutdown coordination and system upgrades.

Support equipment installation, commissioning, and qualification activities.

Manage and coordinate external contractors and service vendors to ensure safe and efficient execution of work.

Continuous Improvement

Recommend and implement facility and utility improvements to enhance reliability and efficiency.

Drive performance improvements using facility and utility KPIs.

Contribute to long-term system reliability strategies and sustainability initiatives.

Training & Conduct

Participate in required technical and compliance training programs.

Maintain a professional approach aligned with company standards and ethical conduct.

Qualifications

Required :

Bachelor's degree in Engineering or related field, or equivalent experience.

Minimum 2 years of experience in utilities or facilities engineering within a GMP environment.

Hands-on experience with HVAC, chillers, compressors, pumps, and related systems.

Proven experience managing CAPAs, change controls, and deviations.

Strong knowledge of OSHA and environmental regulations.

Demonstrated ability to lead small capital or site projects.

Excellent communication, planning, and decision-making skills.

Customer-focused and solutions-oriented mindset.

Preferred :

Experience in biotech or biopharmaceutical manufacturing environments.

Familiarity with CMMS tools (e.g., BMRAM, Maximo, SAP PM).