HEPA Certification and Maintenance Technician

Core Hours

Monday - Friday, 6:00 am - 2:30 pm

Purpose and Scope

The HEPA Certification & Maintenance Technician is responsible for managing the advanced testing, certification, and maintenance of HEPA-filtered cleanroom environments in compliance with cGMP, ISO, and FDA regulations. This role ensures that all controlled environments meet stringent air quality and performance standards critical to pharmaceutical manufacturing and research operations.

Essential Duties & Responsibilities

• Coordinate with internal departments and third-party vendors for HEPA filter testing, certification, and replacement in accordance with the specified frequency.
• Perform routine and non-routine HEPA filter integrity testing (DOP/PAO), airflow visualization, and particle count testing in cleanrooms, laminar flow hoods, biosafety cabinets, and isolators.
• Certify cleanroom environments to ISO 14644, USP <797>/<800> and FDA standards.
• Prepare and maintain comprehensive HEPA certification reports, including test results, compliance documentation, deviations, and corrective actions, in accordance with cGMP, ISO 14644 and FDA requirements.
• Trouble shoot and repair airflow and filtration systems, including fan filter units (FFUs) and HVAC components.
• Maintain accurate and detailed documentation of all certification activities, including test results, deviations, and corrective actions.
• Perform basic maintenance operations on facility/utility, and HVAC equipment, including filter change-out, log readings, etc.
• Assist Maintenance Technicians in performing repairs and preventative maintenance activities on equipment and utilities as needed.
• Perform basic troubleshooting on plant and clean utility systems.
• Provide maintenance support for engineering projects that involve room hepa filter modifications.
• Enter all data into the work order system in a timely manner.
• Assist in the development and revision of SOPs related to job role.
• Perform various housekeeping duties (work areas, equipment, mechanical room).
• Process purchase requisitions and order parts and accessories as required.
• Maintain cGMP Training as required.
• Responsible for assisting with the spare parts inventory for assigned equipment.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Perform other duties as assigned.

Knowledge, Skills & Abilities

• Proficiency in basic computer operations, including Microsoft Office applications (Word, Outlook, Excel, and PowerPoint).
• Proficiency with testing equipment and interpreting technical data.
• Excellent attention to detail and documentation practices.
• Ability to operate hand and power tools in a safe and efficient manner.
• Ability to work independently and be self-motivated.
• Good verbal and written communication skills.
• Good mechanical aptitude with the ability to independently diagnose mechanical equipment issues
• Ability to work well with employees and outside contractors.

Core Values

The HEPA Certification & Maintenance Technician is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• High school diploma or GED required.
• One or more years of experience assisting in the certification of HEPA filters in a cGMP environment or equivalent experience in GMP environment.
• Four or more years of experience in one of the following areas: facilities, utilities, equipment, HVAC education or certification, maintenance operations or equivalent combination of education and experience.
• Experience working with one or more of the following areas: HVAC, Purified/DI Water, steam systems, hot water systems, clean utilities (clean steam, Water for Injection, etc.) preferred.

Working Conditions

• Manufacturing, laboratory, and warehouse environment.
• Work environment will include but is not limited to office, outdoors, mechanical rooms, manufacturing suites, and laboratories.
• Requirements may include working evenings, weekends and some holidays as required including being "on-call" as needed
• Must be able to stand for long periods of time, squat, kneel and lift a minimum of 50lbs.

Compensation and Benefits

• Pay: $35.00 to $39.00 per hour, depending on experience
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.