GMP Facilities Engineer II – HVAC & Clean Utilities Lead

Anika; Bedford (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Discretionary bonus

Healthcare benefits

401(k) with company match

Employee stock purchase plan

Paid time off

Long-term incentives

Job summary

Anika is seeking a Facilities Engineer II in Bedford, MA to lead design, operation, and maintenance of critical facility systems for GMP manufacturing. You will serve as a SME for HVAC, clean utilities, and infrastructure, and you will support capital projects, validation activities, and long-term engineering strategy.

Responsibilities include ensuring regulatory compliance, driving reliability, and partnering with Quality, Validation, MSAT, IT, and vendors.

Qualifications

• 8+ years of facilities engineering experience in regulated manufacturing environments.

Responsibilities

• Leads design, operation, maintenance, and continuous improvement of critical facility systems.
• Supports CQV activities and validation documentation (IQ/OQ/PQ).
• Ensures compliance with FDA cGMP, ISO 14644, EU GMP Annex 1, and ISO 13485.
• Mentors facilities engineers and project teams.
• Collaborates with Manufacturing, Quality, Validation, and external partners.

Skills

Project management

Technical leadership

Analytical problem-solving

Cross-functional collaboration

Strong communication

Technical writing

Root cause analysis

Education

Bachelor’s degree in Mechanical Engineering

Tools

Building Management Systems (BMS)

Environmental Monitoring Systems (EMS)

Job description

Anika is seeking a Facilities Engineer II in Bedford, MA to lead design, operation, and maintenance of critical facility systems for GMP manufacturing. You will serve as a SME for HVAC, clean utilities, and infrastructure, and you will support capital projects, validation activities, and long-term engineering strategy.

Responsibilities include ensuring regulatory compliance, driving reliability, and partnering with Quality, Validation, MSAT, IT, and vendors.