Associate Manager, GMP Maintenance

About Forge

Our mission at Forge Biologics, a member of Ajinomoto Bio-Pharma Services, 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 Associate Manager of GMP Mechanical Maintenance is responsible for the overall preventative, predictive and corrective maintenance strategies of GMP manufacturing, laboratory, and utility equipment in accordance with the OEM recommendations, best practices and internal SOPs. The Associate Manager, GMP Mechanical Maintenance utilizes the latest tools and technologies to drive equipment and system uptime, performance and overall reliability.

What You'll Do:

• Design and implementation of robust preventive maintenance strategies for critical site assets.
• Implements strategies from the Asset Responsible Care Program.
• Trains staff on latest maintenance techniques and best practices.
• Provides mechanical maintenance expertise and asset maintainability expertise during project reviews from engineering conceptualization through detailed design and start-up.
• Supports new equipment installations and Site Acceptance Testing (SAT).
• Leads planned and corrective work on GMP and non-GMP mechanical equipment in accordance with internal procedures meeting all Quality and EHSS requirements.
• Implements a structure for daily rounds which focuses on and documents utility equipment performance.
• Evaluates and implements best practices for in-house vs external maintenance work.
• As applicable, manages contractor services on externally performed equipment preventative and corrective maintenance. Assesses all provided documentation for cGMP and GDP principles.
• Interfaces with various departments to complete equipment maintenance and repairs including Manufacturing, Quality Control, Process Development, Facilities and other departments while minimizing downtime. Works with departments on hand-over of equipment after maintenance and ensures its performance during re-start.
• Develops JSAs for associated work.
• Supports implementation and continued maintenance of the LOTO program.
• Supports periodic review of equipment performance and identifies areas for continuous improvement
• Leads/supports equipment deviation investigations as required.
• Write, edit and review maintenance procedures including WI (Work Instructions) and WPTs (Work Plan Templates). Develops standardized approach to WPTs.
• Maintains knowledge and troubleshooting proficiency for process equipment systems. Troubleshoot utility systems including RO, HVAC, Steam Generation, Chilled Water, Hot Water and Compressed Air.
• Develops and maintains troubleshooting narratives for equipment systems.
• Actively monitors and pulls trends for critical systems tied to the Building Management Control System (Metasys). Responds to alarms from the Building Control System. Reports findings to associated equipment owners.
• Actively monitors and pulls trends from the Building Monitoring System (OceaSoft). Reports trends and other information to the associated equipment owners.
• Part of the monthly planned work order review process and end of month reconciliation of work completed.
• Uploads completed mechanical preventative maintenance documentation and other corrective maintenance work into the Maintenance CMMS system (Blue Mountain Regulatory Asset Manager (BMRAM)) while adhering to Good Documentation Practices.
• Plays a critical role in the development and maintenance of the spare parts program.
• Support Factory Acceptance Testing (FAT).
• Partner with the Manager Plant & Reliability Engineering to identify areas for continuous improvement.
• Troubleshooting and support after hours as required or on-call (response to building management and building monitoring systems).

What You'll Bring:

• 8+ years of experience maintaining complex mechanical equipment/systems.
• Demonstrated leadership abilities, with experience managing teams and driving results in a dynamic environment.
• Familiarity with GMP guidelines and regulatory requirements related to mechanical maintenance activities.
• Strong knowledge of mechanical systems and equipment commonly used in GMP manufacturing environments, including, RO, HVAC systems, Steam Generation, Chilled Water, Hot Water and Compressed Air, and utilities.
• Effective communication skills reporting mechanical issues as it relates to product quality. Effective troubleshooting resolution and communication.
• Excellent problem-solving skills, with the ability to analyze complex issues and implement effective solutions.
• Experience with the selection of mechanical equipment.
• Proficiency in computerized maintenance management systems (CMMS) and management of documentation.
• Flexibility to work off-hours and respond to maintenance emergencies as needed.
• Preferred: Experience in documentation management within a structured Quality System (ISO, FDA).

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
• Flexible 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 - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches