Technician, Manufacturing Shared Services (On-site)

About the role

Positions support drug product development and GMP clinical supply of sterile dosage forms at the Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, NJ. These roles are part of the FLEx-Sterile team, specifically in Manufacturing Shared Services which supports sterile supply, aseptic formulation and visual inspection.

Responsibilities

• Perform hands-on processing activities including equipment assembly and disassembly, sterile processing, inventory management, open aseptic formulation in an isolator and closed formulation activities in a Grade C environment, and manual visual inspection of filled units (i.e. vials or syringes).
• Partner with and support formulation development colleagues in further understanding and knowledge capture of processes, including providing feedback on product and process development.
• Adhere to GMP procedures and maintain strong attention to detail in completing GMP documentation.
• Demonstrate proficiency in electronic systems.
• Participate in continuous improvement projects.
• Support commissioning, qualification, and demonstration of new equipment and technologies.
• Collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline.
• Read, understand, and follow drawings to assemble sterile equipment for clinical development and manufacturing processes.
• Operate and maintain cleaning and sterilization equipment, including parts washers, dry heat ovens, and autoclaves.
• Receive, inspect, and store sterile supplies and equipment, ensuring proper inventory levels and organization within the sterile supply area.
• Prepare and formulate sterile products according to established protocols and batch records, ensuring accuracy and compliance with GMP standards; perform closed formulation activities as well as open aseptic activities inside a Grade A isolator.
• Perform visual inspections of products and components to identify defects, inconsistencies, and non-conformities; manage a large quantity of units with strong attention to detail.
• Maintain meticulous records of formulation processes, including ingredient quantities, equipment used, and environmental conditions.
• Follow all GMP guidelines and standard operating procedures (SOPs) to ensure quality and safety of clinical production lots.
• Identify and address compliance, environmental, safety, and process deviations as appropriate while notifying management.
• Quickly adapt to changes in batch procedures and production schedules, demonstrating flexibility and problem-solving skills.
• Gown and work in Grade C conditions, maintaining good aseptic cleanroom behaviors.
• Maintain accurate records of sterilization processes, inventory levels, and equipment logs in an electronic system.
• Communicate clearly with team and work closely with other teams to ensure on-time delivery of supplies.
• Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards.
• Identify and escalate issues, perform basic troubleshooting, and capture learnings to improve systems and processes.
• Attend and actively participate in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
• Support investigations and implementation of corrective/preventative actions.

Requirements

• High School Diploma/GED or higher.
• Minimum of 2 years of relevant GMP Pharmaceutical experience.
• Demonstrated written and verbal communication skills.
• Proficiency in computer systems and applications including Microsoft Office (Word, Excel and Outlook), Equipment HMI use, SAP, Calibration/Maintenance Database Systems.
• Must be able to pass eye exam for detailed inspection activities.
• Must be able to pass respiratory assessment for respirator use.
• Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and don & wear cleanroom protective gowning including respirators.
• Demonstrated ability to work and communicate both independently and as part of a team.
• Flexibility working overtime is a requirement in manufacturing.

Preferred qualifications

• At least 2 years GMP manufacturing/processing experience.
• Familiarity with regulatory requirements and Good Documentation Practices (GDP).
• Experience with some of the following: highly complex and state of the art equipment, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, visual inspection of product in glass vials, SAP or other ERP systems.
• Associates Degree in science or related field.
• BioWork Certificate (working in an FDA or similar regulated industry).
• Experience with automated systems (MES, SAP, or similar).
• Demonstrated troubleshooting / problem-solving skills.

Pay & benefits

Salary range: $55,900 – $88,100. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

Additional compensation: The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits: Comprehensive package including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days.