Associate Technician, Filling Operations - Onsite (2nd shift)
About The Position
Pharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in their Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center. This position supports drug product development and GMP clinical supply of sterile dosage forms, specifically for filling, as part of the FLEx-Sterile team. The role involves hands-on processing activities including room setup, equipment and material preparation, equipment assembly and disassembly, cleaning, and processing raw materials into finished drug product. Individuals are expected to partner with formulation development colleagues to understand and capture process knowledge, providing feedback on product and process development. Adherence to GMP procedures, strong attention to detail in completing GMP documentation, and proficiency in electronic systems are required. The role also involves participation in continuous improvement projects and may support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate with formulators, engineers, Quality, Safety, and Facilities management to ensure the success and performance of the area and clinical pipeline.
Requirements
- High School Diploma/GED or higher
- Demonstrated written and verbal communication skills.
- Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Equipment HMI use, SAP, Calibration/Maintenance Database Systems.
- 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 a part of a team.
- Flexibility working overtime is a requirement in manufacturing
Nice To Haves
- Experience with machine operations, electronics, or similar technology.
- BioWork Certificate (for working in an FDA or similar regulated industry).
- Demonstrated troubleshooting / problem-solving skills.
Responsibilities
- Prepares, operates, and cleans equipment and facilities used in clinical development and manufacturing processes.
- Maintains, inventories, and transports required processing equipment, materials, supplies, and products.
- Executes all documentation and clerical functions necessary to maintain good manufacturing practice (GMP) operations, using paper-based and electronic systems.
- Maintains detailed knowledge of process equipment and operations.
- Troubleshoots equipment/systems to resolve issues and aid in technology and process development, and provides feedback to improve systems and processes.
- Attends and actively participates in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
- Supports investigations and implementation of corrective/preventative actions.
Benefits
- annual bonus
- long-term incentive, if applicable
- comprehensive package of benefits
- medical healthcare benefits (for employee and family)
- dental healthcare benefits (for employee and family)
- vision healthcare benefits (for employee and family)
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate days
- sick days
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
