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Senior Process Engineer

Company: PACT Pharma
Location: South San Francisco
Posted on: May 3, 2021

Job Description:

DescriptionPACT Pharma is an exciting, well-funded clinical stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient's individual tumor and engineering T cells to kill that specific tumor. In principle, this technology can be used to treat any cancer type. If you desire a stimulating fast paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team. We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer! We are in the San Francisco bay area, the heart of the world's premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants. We are currently recruiting for a Senior Process Engineer who will report to the Associate Director of Process Engineering and be responsible for assessing requirements ,deploying capital equipment and technical infrastructure solutions, and assessing effectiveness across broad range of production processes. The ideal candidate should be creative and interdisciplinary with practical problem-solving skills and hands-on experience in the areas of biologics manufacturing, laboratory automation, liquid handling, and instrumentation qualification and validation. This will be a unique opportunity to see your solutions transform the way we process patient samples, improving PACT's throughput and turnaround time, and directly impact patient lives. Responsibilities: Work with the operations and process development teams to fully map and understand process timings, material flow, hands-on-time, cost, quality, and throughput Design and execute studies and data gathering exercises for new and existing protocols to characterize instrumentation and assay performance and improve reproducibility and reliability Work with the software and automation engineering teams to develop and deploy automated software and robotic solutions throughout the production lab Work with end users to understand and document requirements and validate that those requirements are met through verification and validation Coordinate the project lifecycle in partnership with PMO and Quality to define solutions, run FMEAs, and ensure the systems that you deploy are fit for purpose Identify continuous improvement projects as well as opportunities for technological innovation and process development Author equipment documentation, SOPs, and work instructions in accordance with PACT's quality management system Communicate clearly and concisely, both verbally and in the form of written reports Qualifications:Bachelor's or master's degree with 5+ years of process engineering experience in pharmaceutical or biotech 3+ years' experience investigating, developing, and implementing new manufacturing processes and improving existing processes in the areas of biologics manufacturing Experience operating within a formal quality management system such as cGMP or ISO 13485 and familiarity with 21 CFR part 11 is required Experience developing, implementing and improving manufacturing line layouts and processes in an automated laboratory setting Strong understanding and knowledge of Lean manufacturing concepts (pFMEA, Value Stream Mapping, Kaizen, 5S, 6-sigma) Experience integrating laboratory processes and equipment into LIMS, informatics, MES or data management systems Ability to analyze and manipulate complex scientific and operational datasets and to communicate findings/recommendations Experience implementing IQ/OQ/PQs and understanding of process performance qualifications Familiarity with formal process validation and/or v-model life cycle development Experience operating within a turnaround time sensitive production environment Highly goal-driven and have demonstrated the ability to focus on time-sensitive objectives Experience with plasmid and cell manufacturing is a plus PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate on the basis of race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.

Keywords: PACT Pharma, South San Francisco , Senior Process Engineer, Other , South San Francisco, California

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