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

JOB 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.

+ 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.

Primary Responsibility in %

1. Precisely follow company **tissue requests,** study designs, protocols and SOP’s for the complete **processing of tissue based** products 40%

2. Perform lab testing to demonstrate the ability of the product/device to function as intended (i.e. verification and validation of process). 15%

3. Assist in the development of processes for manufacturing and commercial tissue products. 5%

4. Work with the in-house manufacturing group to scale-up, validate, and transfer the commercial manufacturing process 5%

5. Monitor the performance of processes and equipment and make recommendations for continuous improvement 10%

6. Serve as a subject matter expert, provide guidance to junior staff

7. Train new employees

8. Operates heat sealers, biohClientard laminar flow hoods, aspiration systems, weighing scales, orbital shakers, splitter, grinder, gerber table, mixers.

9. Records information on batch records, equipment and cleaning logs, and other documents

10. Maintains inventory of processing supplies

11. 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

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)

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

Nice to have (but not required)

• 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 Manufacturing, but not test tube.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.