Senior GMP Facilities Engineer: HVAC & Utilities

ANIKA-GCC; Bedford (MA); On-site; USD 84,000 - 106,000; Full time

Benefits offered by this job

Discretionary bonus

Comprehensive healthcare benefits

Health savings account

401(k) plan with company match

Employee stock purchase plan

Paid time off

Long-term incentives including stock

Job summary

Anika in Bedford, MA is seeking a Facilities Engineer II to lead design, operation, and lifecycle management of critical GMP facility systems. You will specialize in HVAC, clean utilities, and validated environments while partnering on CQV activities and capital projects.

We value strong technical leadership, project management, and the ability to collaborate across Manufacturing, Quality, Validation, and Vendors to deliver reliable, compliant facilities.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 8–12 years of facilities engineering experience in biopharmaceutical/aseptic environments.
• Demonstrated expertise in HVAC design, operation and maintenance for GMP manufacturing.
• Strong knowledge of clean utilities (PW, WFI, clean steam, compressed gases).
• Experience supporting CQV activities and maintaining validated systems.

Responsibilities

• Lead performance, reliability, and lifecycle management of HVAC systems for GMP facilities.
• Ensure compliance with FDA cGMP, ISO 14644, EU GMP Annex 1, and ISO 13485.
• Oversee HVAC equipment (AHUs, chillers, HEPA, etc.) and clean utility systems.
• Support commissioning, qualification, and validation (IQ/OQ/PQ) activities.
• Develop preventive and predictive maintenance strategies and CMMS integration.
• Collaborate with multiple functions to drive capital projects from concept to handoff.
• Mentor facilities engineers and project teams.
• Maintain audit-ready, validated facility infrastructure.

Skills

HVAC systems

Regulatory compliance

Project management

Cross-functional collaboration

Root cause analysis

Education

Bachelor's degree in Mechanical Engineering

Tools

BMS

EMS

Job description

Anika in Bedford, MA is seeking a Facilities Engineer II to lead design, operation, and lifecycle management of critical GMP facility systems. You will specialize in HVAC, clean utilities, and validated environments while partnering on CQV activities and capital projects.

We value strong technical leadership, project management, and the ability to collaborate across Manufacturing, Quality, Validation, and Vendors to deliver reliable, compliant facilities.