Facilities Engineer II

Anika Therapeutics•Bedford, MA

8d•$110,000 - $125,000•Onsite

About The Position

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.

Requirements

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 Haves

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.

Responsibilities

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.