Sr. Calibration & Controls Technician

About Forge

Our mission at Forge Biologics, is to enable access to life changing gene therapies and help bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.

About The Role:

The Sr. Calibration and Controls Technician is responsible for the overall calibration and controls maintenance and continuous improvement of GMP manufacturing, laboratory and utility equipment and control systems in accordance with the OEM (Original Equipment Manufacturer) recommendations and internal SOPs.

What You’ll Do:

Assess instrumentation and control systems as part of the equipment onboarding process. Provide guidance on appropriate instrumentation and control systems to be implemented as part of the site standardization strategy. Identifies new calibration standards as required

Participate in project reviews from engineering conceptualization through detailed design and start-up for the selection of instrumentation and controls

Perform initial new equipment calibrations as required

Performs planned calibrations and corrective work on instrumentation in accordance with internal procedures

Assists with contractor management on externally performed calibrations, including obtaining quotes and contracts, scheduling, on-site escorting, supervision, and providing training that ensures all applicable documentation is in accordance with internal procedures

Interfaces with various departments to complete calibrations, while minimizing equipment downtime - including Manufacturing, Quality Control, Process Development, Facilities and other departments as applicable

Communicates as found instrument OOT (Out of Tolerance) to the department equipment owners and reports OOT to the Calibration and Controls Lead. Initiate deviations for OOT events in the Quality Management System. Acts as SME in investigations as required

Supports periodic review of instrument OOTs and proposes areas for improvement or correction

Write, edit and review calibration procedures

Uploads completed calibration documentation and other corrective work into the Maintenance CMMS system (Blue Mountain Regulatory Asset Manager (BMRAM)), while adhering to Good Documentation Practices

Identify critical spare instrumentation and controls components

What You’ll Bring:

5+ years of related experience in calibration and controls

Extensive experience installing, maintaining, testing, repairing, and calibrating a wide range of complex equipment within a cGMP environment, or other highly regulated environment preferred

Effective communication skills reporting calibration and controls issues as it relates to product quality. Effective troubleshooting resolution and communication skills

Ability to troubleshoot problems within complex instrumentation and control systems, identify root causes and propose and implement solutions

Experience with the selection of calibration standards and calibration software programs

Experience with CMMS related systems and management of documentation

Proficiency in calibrating various types of instruments and equipment, such as temperature, pressure, flow, and level transmitters

Ability to troubleshoot, maintain, and repair control systems, such as PLCs (Programmable Logic Controllers), SCADA (Supervisory Control and Data Acquisition) systems, and DCS (Distributed Control Systems)

Troubleshooting and support after hours as required (response to building management and building monitoring systems)

Experience in documentation management within a structured Quality System (ISO, FDA) is preferred

Physical Requirements:

May be required to lift up to 50 pounds of materials or equipment

Requirement to gown into Classified Areas of the facility (ISO 7 and 8 sterile gowning)

The ability to move safely over uneven terrain or in confined spaces

The ability to safely climb ladders while carrying 40 pounds

The ability to wear personal protective gear correctly as required

Work Environment and Physical Demands

This position works in both a warehouse and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The noise level in the work environment ranges from moderate to occasionally loud. Must be able to lift, carry, push, and/or pull objects weighing up to 35 lbs. Ability to frequently operate a computer, and communicate with others in person, over the phone, and via other devices. Must be able to move about the facility for moderate to extended periods of time. Ability to wear task dependent personal protective equipment as needed.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge’s core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.

HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.

OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge’s vision, mission and goals.

We’ve Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents

Competitive PTO (plus 14 paid company holidays)

Annual bonus for all full-time employees

401(K) company match

Fully-stocked kitchen with free food/drinks

12 weeks of paid parental leave - additional discount programs include childcare support & dependent care

Employee Assistance Program

Wellness benefits (financial planning services, mental health counseling, employer paid disability)

Professional & Personal development resources

Onsite gym