Job Title: Process Development Technician
Duration: 6 months (possible extension)
Schedule: First Shift (7:00 AM - 3:30 PM), with flexibility
Location: Branchburg NJ, 08876
Overview:
The Process Development Technician is responsible for executing the processing of human, porcine, and fat-based tissue products in a laboratory setting. This role requires cleanroom gowning, strict adherence to protocols, and a strong attention to detail. The technician acts as a subject matter expert (SME), ensuring smooth execution of processing activities and compliance with quality and safety standards.
This role involves physical activity, including lifting up to 30 pounds and frequent sitting, walking, reaching, stooping, squatting, kneeling, and stair climbing. Fine motor skills are required to operate various equipment and machinery. The technician must be able to work in both cleanroom and non-climate-controlled environments and handle chemicals such as solvents and disinfectants safely.
Key Responsibilities
- Follow detailed tissue requests, study designs, protocols, and SOPs to ensure accurate and compliant tissue processing
- Perform laboratory testing to verify and validate tissue product functionality
- Assist in the development and refinement of tissue manufacturing processes
- Collaborate with internal manufacturing teams to support process scale-up, validation, and transfer
- Monitor and evaluate process and equipment performance; provide input on improvements
- Serve as a subject matter expert and provide guidance to junior team members
- Train new employees on processing techniques, equipment usage, and safety procedures
- Operate a range of laboratory equipment, including heat sealers, laminar flow hoods, orbital shakers, grinders, mixers, and scales
- Accurately complete batch records, equipment logs, and cleaning documentation
- Maintain inventory of processing supplies and ensure proper usage
- Enter data and generate reports using company computer systems
Required Qualifications
- Associate's degree
- 3-5 years of experience in a regulated, laboratory, or manufacturing setting
Preferred Qualifications
- Experience with tissue-based product development
- Background in Quality or R&D environments
Essential Skills and Competencies
- Strong interpersonal and communication skills for effective team collaboration
- Working knowledge of Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP)
- Experience in aseptic processing and cleanroom environments
- Proficiency in operating manufacturing equipment used in the medical device or tissue processing industries
- Ability to work independently and with minimal supervision
- Capable of lifting up to 25 pounds and performing physically demanding tasks
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