Facilities Engineer II

ANIKA-GCC

Bedford (MA)

On-site

USD 84,000 - 106,000

Full time

4 days ago

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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

Job Description

The Facilities Engineer II leads the design, operation, maintenance, and continuous improvement of critical facility systems supporting GMP manufacturing operations, ensuring reliability, regulatory compliance, and operational performance. In this role, you serve as a subject matter expert in HVAC systems, clean utilities, and facility infrastructure while supporting capital projects, validation activities, and long-term engineering strategy.

What You’ll Contribute

Leads the performance, reliability, and lifecycle management of HVAC systems supporting GMP manufacturing areas, including ISO 7 and ISO 8 cleanrooms and other controlled environments.
Ensures facility systems comply with FDA cGMP requirements, ISO 14644, EU GMP Annex 1, ISO 13485, and internal environmental specifications.
Oversees HVAC equipment including air handling units (AHUs), chillers, HEPA filtration systems, terminal units, pressure cascade controls, airflow strategies, and environmental monitoring integration.
Provides technical ownership of clean utility systems including purified water (PW), water for injection (WFI), clean steam, and clean compressed gases, as applicable.
Leads investigations, troubleshooting, and resolution of HVAC and clean utility deviations while driving long-term system reliability and performance improvements.
Partners with Quality and Validation to support commissioning, qualification, and validation (CQV) activities, including IQ/OQ/PQ protocols, change controls, deviations, and CAPAs.
Maintains facility systems in a validated, inspection-ready state and supports customer, regulatory, and internal audits.
Leads or supports capital projects involving facility and utility upgrades from concept through commissioning, startup, and operational handoff.
Develops and reviews engineering documentation including P&IDs, user requirements specifications (URS), design specifications, equipment layouts, and engineering calculations.
Establishes and optimizes preventive and predictive maintenance strategies while supporting CMMS programs and asset management initiatives.
Monitors facility performance using key performance indicators to improve equipment reliability, uptime, and energy efficiency.
Identifies and implements continuous improvement initiatives focused on energy reduction, sustainability, system capacity optimization, and operational excellence.
Collaborates with Manufacturing, Quality, Validation, MSAT, IT, EHS, vendors, contractors, and external engineering partners to support facility performance and business objectives.
Provides technical leadership and mentorship to facilities engineers, maintenance personnel, and project teams.
Performs other duties and projects as assigned.

What It Takes

This position requires advanced technical expertise in facility engineering and the ability to solve complex engineering challenges within highly regulated manufacturing environments. The role exercises significant judgment in the design, operation, maintenance, and improvement of critical facility systems where decisions directly impact product quality, regulatory compliance, manufacturing continuity, and operational efficiency. Success requires strong technical leadership, project management, analytical problem-solving, and the ability to effectively collaborate across multiple engineering and operational disciplines.

What You Bring

Bachelor’s degree in Mechanical Engineering or a related engineering discipline.
8–12 years of facilities engineering experience supporting biopharmaceutical, medical device, or aseptic manufacturing operations.
Demonstrated expertise in the design, operation, and maintenance of HVAC systems supporting GMP manufacturing environments.
Strong experience with clean utility systems, including purified water, water for injection, clean steam, and clean compressed gases, as applicable.
Thorough understanding of cleanroom environmental control, HVAC control strategies, pressure differentials, temperature, humidity, and airflow management.
Experience supporting commissioning, qualification, and validation (CQV) activities and maintaining systems in a validated state.
Strong working knowledge of FDA cGMP requirements, EU GMP Annex 1, ISO 14644, and ISO 13485.
Experience supporting regulatory inspections and customer audits.
Excellent communication, technical writing, project management, and cross-functional collaboration skills.
Demonstrated ability to analyze complex technical issues, perform root cause investigations, and implement effective corrective actions.

Nice to Have

Professional Engineer (PE) license.
Experience supporting aseptic fill-finish or sterile manufacturing facilities.
Familiarity with Building Management Systems (BMS) and Environmental Monitoring Systems (EMS).
Experience applying ASTM E2500 commissioning and qualification principles and ICH Q9 risk management methodologies.
Experience with energy modeling, sustainability initiatives, and carbon reduction strategies.
Experience managing EPCM firms, engineering consultants, and external contractors.
Lean manufacturing or continuous improvement experience focused on facilities operations.

Compensation & Benefits

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.