Manufacturing Associate (Clean Room/Aseptic Processes/GMP)

First shift schedule with flexibility (7am-3:30pm).

SUMMARY:

• The Process Development Tech II position exists for the processing of human, porcine and fat-based tissue products.
• It requires clean room gowning and working in a lab setting.
• The Process Development Tech II serves as a subject matter expert and ensures the continuous flow of processing activities.
• It requires lifting to 30 pounds of boxes and materials off racks.
• The position involves frequently sitting, walking, reaching, stooping, squatting, crouching, kneeling, crawling and stair climbing and has the ability to use fine motor skills to operate equipment and/or machinery.
• Attention to detail is necessary when testing, assessing, and processing tissue samples.
• In addition, the Process Development Tech II requires the ability to comprehend work instructions and safety requirements to enter information into work logs and existing computer systems.
• Finally, the position requires the ability to work with solvents, cleaners and disinfecting products in both clean room and non-climate-controlled environments.

KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE: % of Time or Importance

• Precisely follow company tissue requests, study designs, protocols and SOP’s for the complete processing of tissue based products. 40
• Perform lab testing to demonstrate the ability of the product/device to function as intended (i.e. verification and validation of process). 15
• Assist in the development of processes for manufacturing and commercial tissue products. 5
• Work with the in-house manufacturing group to scale-up, validate, and transfer the commercial manufacturing process. 5
• Monitor the performance of processes and equipment and make recommendations for continuous improvement. 10
• Serve as a subject matter expert, provide guidance to junior staff
• Train new employees
• Operates heat sealers, biohazard laminar flow hoods, aspiration systems, weighing scales, orbital shakers, splitter, grinder, gerber table, mixers.
• Records information on batch records, equipment and cleaning logs, and other documents
• Maintains inventory of processing supplies
• Uses computers to enter data and generate reports

Years of experience/education and/or certifications required:

• Associate’s degree w/ 3-5 years of experience

What are the top 3-5 skills requirements should this person have?

• Excellent interpersonal skills to allow effective participation with project teams
• Understanding of Quality System Regulations (QSR)
• Ability to lift 25 pounds

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

• Prior experience with using manufacturing equipment for the medical device industry
• Prior experience in development of tissue based products is a big plus
• Prior experience in aseptic processes
• Prior experience and understanding of GDP, and GMP

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Quality/ R&D experience

What type of environment is this person working in?

• Process Lab Environment – working with industrial machinery – processing at a higher level. Not Mfg, but not test tube.

Job Type: Contract

Pay: $23.00 - $25.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Cleanroom: 3 years (Preferred)
• CGMP: 3 years (Preferred)
• aseptic processes: 3 years (Preferred)
• development of tissue based products: 3 years (Preferred)
• using mfg equipment for the medical device industry: 3 years (Preferred)

Ability to Commute:

• Branchburg, NJ 08853 (Required)

Work Location: In person

Salary : $23 - $25