Technician I, GMP Manufacturing - Fill/Finish

Forge Biologics•Columbus, OH

13d

About The Position

We are seeking a detail-oriented and highly motivated individual to join our Fill/Finish Manufacturing team. As a Technician I, GMP Manufacturing – Fill/Finish you will play a crucial role in the aseptic filling and finishing operations of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. This position presents an exciting opportunity to contribute to the manufacturing of cutting-edge therapies that have the potential to transform the lives of patients.

Requirements

Associate’s or Bachelor’s degree in a scientific, technical, or related field preferred; or equivalent professional experience.
Previous experience working in a regulated manufacturing or laboratory environment.
Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines.
Strong teamwork and communication skills to collaborate effectively across departments.
Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
Ability to adapt to changing priorities and work independently as well as part of a team.
Strong problem-solving skills and ability to identify and escalate issues as needed.
Willingness to work flexible hours, including evenings, weekends, and holidays to support manufacturing production schedules.
Ability to stand for extended periods, and work in a cleanroom environment while wearing appropriate gowning and PPE.

Nice To Haves

Prior experience working in a cGMP manufacturing environment.
Experience operating and maintaining filling and finishing equipment
Familiarity with aseptic filling equipment and processes, such as semi-automated and automated fillers, stoppering machines, cappers, and labeling machines

Responsibilities

Execute aseptic filling and finishing operations according to Standard Operating Procedures (SOPs) and batch records, ensuring compliance with cGMP guidelines and quality standards.
Prepare and operate filling equipment, such as semi-automated and automated fillers, stoppering machines, cappers, and labeling machines, following established procedures, and ensuring proper setup, calibration, and maintenance.
Perform line clearances, sanitization, and sterilization of equipment and manufacturing areas to maintain aseptic conditions.
Assemble, disassemble, and clean equipment components, ensuring proper sterilization procedures are followed.
Monitor critical process parameters, including fill volumes, stopper/cap placement, torque, and label alignment, and promptly report deviations or abnormalities.
Conduct in-process testing and quality control checks, such as visual inspections, particle count, and container closure integrity tests, to ensure product quality and compliance.
Accurately document manufacturing activities and data in compliance with cGMP regulations and company policies.
Collaborate with cross-functional teams, to investigate and resolve deviations, non-conformances, and quality incidents.
Support process improvement initiatives to enhance efficiency, productivity, and compliance.
Follow safety protocols and environmental health guidelines to maintain a safe workspace.
Participate in training programs and stay updated with current industry trends, regulatory requirements, and advancements in gene therapy manufacturing processes.

Benefits

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 paid time off plan
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)
Onsite fitness facility
Professional & Personal development resources