Description:
First shift schedule with flexibility (7am-3:30pm).
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.
Responsibilities:
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
Skills:
Excellent interpersonal skills to allow effective participation with project teams
Understanding of Quality System Regulations (QSR)
Ability to lift 25 pounds
Qualifications:
Associate s degree w/ 3-5 years of experience
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
Process Lab Environment working with industrial machinery processing at a higher level. Not Mfg, but not test tube.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.