Facilities Engineer II

Anika Therapeutics; Bedford (MA); On-site; USD 84,000 - 106,000; Full time

Benefits offered by this job

Discretionary bonus

Health care benefits

Health savings account (HSA)

401(k) plan with up to 5% companymatch

Employee stock purchase plan at 15%"}

Paid time off

Long-term incentives including stock

Job summary

Anika Therapeutics Bedford, MA is seeking a Facilities Engineer II to lead design, operation, maintenance, and improvement of critical facility systems for GMP manufacturing.

You will specialize in HVAC, clean utilities, and facility infrastructure while supporting capital projects, validation activities, and long-term engineering strategy. 8–12 years of relevant experience preferred.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 8-12 years facilities engineering in biopharmaceutical, medical device, or aseptic manufacturing.
• Experience with design, operation, and maintenance of HVAC systems in GMP environments.
• Strong knowledge of clean utility systems (PW, WFI, clean steam, compressed gases).
• Familiarity with FDA cGMP, ISO 14644, ISO 13485, ISO 14644.

Responsibilities

• Leads HVAC system performance, reliability, and lifecycle management in GMP areas including cleanrooms.
• Ensures facility systems comply with relevant regulatory requirements (FDA, ISO).
• Oversees HVAC equipment like AHUs, chillers, HEPA filtration, and environmental monitoring; supports CQV activities.

Skills

HVAC systems

Clean utilities

Regulatory compliance

Project management

Cross-functional collaboration

Technical leadership

Education

Bachelor's degree in Mechanical Engineering

Tools

CMMS

BMS

EMS

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Regular Full-Time Bedford, MA, US

6 days ago Requisition ID: 1753

Salary Range: $84,000.00 To $106,000.00 Annually

What You'll Do

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.

How 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.

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. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.

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.