Newark Metro Area, NJ
The Process Development Technician position exists for the processing, testing and analyzing tissue samples/data under moderate to minimal supervision.
It requires clean room gowning and working in a lab setting. The Process Development Technician serves as a subject matter expert and ensures the continuous flow of processing activities. Tech III also executes tissue assays and may assist in the analysis of the data generated from the assays.
Essential Job Functions:
This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
*Precisely follow company tissue requests, study designs, protocols and SOP s for the complete processing of tissue base products with minimal supervision.
*Perform routine lab testing to demonstrate the ability of the product/device to function as intended under study director/management supervision.
* Contribute to the development of processes for manufacturing and commercial tissue products.
*Work with in-house engineering groups to scale-up, validate, and transfer the commercial manufacturing process.
*Monitor and analyze the performance of processes and equipment and make recommendations for continuous improvement with minimal guidance.
*Serve as a subject matter expert, provide guidance to junior staff. Train employees and staff on complex technical methods.
* Independently operates a variety of laboratory and manufacturing equipment.
*Follows Good Documentation Practices when recording information on batch records, equipment and cleaning logs, and other documents.
*Maintains/manages inventory of processing supplies with little to no guidance.
*Ability to independently enter data and generate reports in data entry systems such as MS Office and SAP
Current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements.
Basic chemistry laboratory practices and techniques.
Personal computer hardware and software applications.
Business English usage, spelling, grammar and punctuation.
Basic mathematical computations.
Current Company policies, practices and procedures, including safety rules and regulations.
Physical Requirements and Working Conditions:
Incumbents in this class are subject to extended periods of sitting, standing, walking, lifting materials weighing up to 30 pounds, vision to monitor and moderate to loud noise levels. Incumbents may be exposed to or work with toxic materials, toxic gases, electrical hazards, dangerous tools and equipment. Work is performed in laboratory environments.
High School Diploma or equivalent, with minimum of Three (3) year related experience in Quality laboratory or an equivalent combination of education and experience.