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) match

Job summary

Anika is seeking a Facilities Engineer II in Bedford, MA to lead design, operation, and continuous improvement of critical facility systems supporting GMP manufacturing. The role focuses on HVAC, clean utilities, and regulatory compliance, with CQV collaboration and capital-project involvement.

The ideal candidate brings 8–12 years in biopharma or aseptic environments, strong project management, and experience with FDA cGMP, ISO 14644, and ISO 13485, plus leadership and cross-functional teamwork.

Qualifications

• Advanced technical expertise in facility engineering within regulated manufacturing environments.
• Experience designing, operating, and maintaining HVAC and clean utility systems.
• Experience supporting CQV activities (IQ/OQ/PQ) and validation in GMP settings.

Responsibilities

• Leads design, operation, maintenance, and continuous improvement of critical facility systems in GMP environments.
• Ensures compliance with FDA cGMP, ISO 14644, EU GMP Annex 1, and ISO 13485.
• Supports commissioning, qualification, validation and CAPA activities with CQV teams.
• Mentors facilities engineers and maintenance staff; collaborates cross-functionally to meet objectives.
• Leads or supports capital projects from concept to commissioning and handoff.

Skills

HVAC systems

Clean utilities

Regulatory compliance

CQV support

Project management

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering

Tools

BMS

EMS

Job description

Anika is seeking a Facilities Engineer II in Bedford, MA to lead design, operation, and continuous improvement of critical facility systems supporting GMP manufacturing. The role focuses on HVAC, clean utilities, and regulatory compliance, with CQV collaboration and capital-project involvement.

The ideal candidate brings 8–12 years in biopharma or aseptic environments, strong project management, and experience with FDA cGMP, ISO 14644, and ISO 13485, plus leadership and cross-functional teamwork.