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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Process Engineer

Job Description

  • Location: Summit, NJ
  • Type: Contract
  • Job #72001

Our client, a leading pharmaceutical company, is hiring a Process Engineer on a contract basis.

Work Location

Summit, NJ

Summary

We are looking for an Engineer, to join our Tech Transfer team in GMS&T.

The successful candidate will work under the tech transfer lead to support process and analytical clinical and/or commercial transfers, support and implement lifecycle changes, and support the training and start-up of new facilities.

He/she will collaborate with SMEs, user groups, quality groups, and other stakeholders to support the lead to accomplish transfer and start-up goals including: support facility design, provide user specification, process simulations, transfer lot generation, comparability studies, test plan generation, operator training, and troubleshooting. He/she will also participate in strategic discussions, anticipate bottlenecks and transfer risks, and address risks/issues proactively, while fostering an environment of teamwork.

 

Duties/Responsibilities:

 

• Support the Tech Transfer Lead and interface with process SMEs to develop transfer strategies

• With direction of the Tech transfer Lead, support the following activities:

• Interface with manufacturing site operations teams and process/analytical SMEs to learn and implement processes, procedures, and analytics

• Support facility start-up efforts through specification, review, and testing of equipment and electronic systems

• Coordinate project planning, timeline, communications, and risk management activities

• Support manufacturing, QC and QA throughout transfer by providing training, answering questions, clarifying intent of procedures, solving problems, and contributing to operational strategies

• Provide technical input and investigation support for deviations/OOS

• Assist in the management of changes, and in the implementation of process improvements

• Provide technical input in support of regulatory submissions

• Interact with other CMC teams including Operations, QA, Development, and Regulatory

• Foster strong inter-team relationships to achieve common project goals

 

QUALIFICATIONS

• Candidate must have previous Technical Transfer experience

• Strong experience with SOPs, change controls, cGMPs and the know how to work within a regulatory environment

• Established track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting

• Familiarity with literature on process development and cell therapy

• Ability to assess risk and develop contingency plans for process risks

• Excellent problem-solving skills, including issue resolution

• Detail oriented with excellent verbal and written communication skills

• Strong interpersonal and leadership skills to work with teams in different functions and organizations

 

Education/Experience/ Licenses/Certifications:

• B.S. with 12+ years, M.S. with 10+ years in industry with relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline

• Experience in leading Technical Transfers

• Experience with cellular therapies is strongly preferred

• Experience in a regulated manufacturing environment

• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.

 

 

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