GMP Equipment Monitoring Technician - 3rd Shift - Gene Therapy Manufacturing Expert

Join the Vanguard of Gene Therapy Development at Forge Biologics

Embark on a career journey with Forge Biologics, a pioneering gene therapy development engine that's redefining the future of medicine. As a member of Ajinomoto Bio-Pharma Services, we're at the forefront of enabling access to life-changing gene therapies, transforming ideas into reality for patients worldwide. Our state-of-the-art 200,000 square foot facility, affectionately known as The Hearth, in Columbus, Ohio, is dedicated to AAV manufacturing, offering scalable, end-to-end manufacturing services.

About the Role: GMP Equipment Monitoring Technician - 3rd Shift

We're seeking a skilled and detail-oriented GMP Equipment Monitoring Technician to join our team on the 3rd shift. This critical role is responsible for overseeing, gathering, and consolidating manufacturing data from various sources, including production equipment, quality control systems, and laboratory instruments. As a GMP Equipment Monitoring Technician, you will be the linchpin in ensuring the smooth operation of our manufacturing processes, driving equipment performance, and maintaining compliance with regulatory standards.

Key Responsibilities

• Continuously monitor GMP and QC equipment to ensure proper functionality, performing regular maintenance and calibration to maintain accuracy and compliance.
• Accurately record equipment performance data and maintenance activities in logbooks, maintaining detailed records for audit and compliance purposes.
• Diagnose and troubleshoot equipment issues promptly, collaborating with Facilities & Engineering (F&E) through Blue Mountain Regulatory Assets Management software to coordinate necessary repairs and replacements.
• Ensure all equipment monitoring and maintenance activities comply with GMP, QC, and regulatory requirements, updating protocols as necessary to reflect regulatory changes.
• Develop and execute preventive maintenance schedules for GMP and QC equipment, proactively identifying potential issues before they impact operations.
• Assist QC teams with equipment setup and operation for testing and analysis, ensuring GMP/QC equipment is properly maintained and ready for use.
• Maintain inventory of spare parts and consumables required for equipment maintenance and repairs, ensuring timely reordering to avoid operational interruptions.

Essential Qualifications and Skills

To excel in this role, you'll need:

• A high school diploma or equivalent; technical certification or relevant experience is preferred.
• Previous experience working with laboratory equipment in a GMP, QC, or regulated environment.
• Strong problem-solving skills and the ability to respond quickly in urgent situations.
• A basic understanding of laboratory and production equipment, including troubleshooting and preventive maintenance practices.
• Excellent attention to detail and the ability to work independently on the 3rd shift (10pm-6am) based on GMP production run schedules.
• Effective communication skills to relay information across shifts and departments.

Preferred qualifications include familiarity with regulatory requirements for data management in a manufacturing environment, specifically for equipment (BMRAM), and an understanding of manufacturing processes in the biotech industry.

Career Growth and Learning Benefits

At Forge Biologics, we're committed to the growth and development of our team members. As a GMP Equipment Monitoring Technician, you'll have opportunities to:

• Collaborate with cross-functional teams to identify opportunities for improving equipment performance and maintenance processes.
• Implement best practices and innovative solutions, driving continuous improvement in our manufacturing operations.
• Develop your skills in a dynamic, regulated environment, with access to professional development resources, including LinkedIn Learning and in-house training staff.

Work Environment and Company Culture

Our work environment is a unique blend of laboratory and office settings, with varying physical demands depending on the task. You'll be required to wear personal protective equipment based on the task and work in confined spaces such as clean rooms or laboratory environments. We're proud of our inclusive and diverse workforce, and we're committed to providing a work environment that's engaging, challenging, and rewarding.

Our core values - HARDWORKING, OPEN, PURPOSE-DRIVEN, and ENGAGED - lay the foundation for our H.O.P.E. culture, providing a common purpose that we all understand, work towards, and live by.

Compensation, Perks, and Benefits

We offer a competitive salary, reflecting your skills and experience, along with a comprehensive benefits package that includes:

• Health, Dental, and Vision insurance starting on your first day, with 90% of premiums covered for team members and dependents.
• Flexible PTO and 14 paid company holidays.
• Annual bonus for all full-time employees.
• 401(K) company match.
• A fully-stocked kitchen with free food and drinks.
• 12 weeks of paid parental leave, with additional discount programs for childcare support and dependent care.
• Employee Assistance Program and wellness benefits, including financial planning services, mental health counseling, and employer-paid disability.

Join Our Team

If you're passionate about making a significant impact in the gene therapy industry, we invite you to apply for this exciting opportunity. As a GMP Equipment Monitoring Technician at Forge Biologics, you'll be part of a dynamic team that's pushing the boundaries of what's possible in gene therapy manufacturing. Apply now and take the first step towards a rewarding new role.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. We provide equal employment opportunities to all employees and applicants for employment, prohibiting discrimination and harassment of any type.

Submit Your Application

Seize this opportunity to make a significant impact. Apply now and take the first step towards a rewarding new role.