| Job Description: | - MAYBE TEMP TO HIRE - DURATION - 6/7 MONTHS - ONSITE POSITION - SHIFT - MON-FRI 8:30AM - 5PM.
POSITION SUMMARY
The MS&T Process Engineer provides technical leadership and support to Princeton, NJ cGMP manufacturing facility that ensures cell therapy processes are robust, scalable and cGMP compliant. The MS&T Process Engineer drives seamless technology transfer, reliable cGMP manufacturing, and continuous improvement to enable the site to deliver safe, high-quality therapies to patients with speed, precision, and operational excellence.
The Process Engineer MS&T will report to the Manager, MS&T.
KEY RESPONSIBILITIES
Process Subject Matter Expert (SME) and process owner for technology transfer and new product introduction.
Perform technology transfer facility, process, workflow, and equipment fit assessment, process gap analysis, and process risk assessment when on-boarding new programs.
Author, review, and approve internal cGMP technical documents (e.g., Batch records, SOPs, Sample Plans, and protocols).
Author and approve protocols and reports per internal and external regulatory expectations.
Provide on-the-floor technical support to manufacturing including process execution and troubleshooting, Quality Event triage, root cause analysis, and CAPA implementation.
Compile, trend, analyze, and summarize cGMP manufacturing data using processing trending and statistical analysis tools.
Identify and implement process improvements and operational efficiencies using data driven approaches.
Represent MS&T as the technical Subject-Matter-Expert on internal and client-facing project teams.
Assist Manufacturing and Supply Chain with new equipment introduction and new material assessment and onboarding.
Support equipment and systems validation activities, including review of equipment qualification documents, drafting User Requirement Specifications, and providing technical input for impact assessments.
Lead lifecycle management and process validation activities, including authoring and approving PV strategies, supporting PPQs, evaluating process changes, and maintaining regulatory alignment during program transition from clinical to commercial phases.
Work with Process Development to identify, test, and implement new technologies and capabilities for the cGMP manufacturing facility.
Identify and maintain relationships with vendor representatives of supplies, instruments, and equipment.
Support site-wide measurement of KPI's related to Delivery, Cost, Quality, and Safety.
Assist with the training of new employees as needed.
Some travel will be required.
Other job duties as assigned.
POSITION REQUIREMENTS
BSc and/or Advanced degree in Science or Chem/Bio Engineering
Minimum 5 years of industry experience.
Minimum 3 years relevant experience in cGMP biologic/cell therapy manufacturing, technical or process development role.
Advanced degree(s) preferred.
Scientific understanding in bioprocessing principles. Familiarity with cell therapy processes, cleanroom facilities and equipment is strongly preferred.
Demonstrated understanding of Title 21 CFR Part 11 and 21 CFR Parts 210 and 211 cGMP regulations, including their application to cGMP facilities, personnel training, equipment, materials, records, documents, manufacturing processes, packaging, and labeling.
Experience in equipment and process qualification and validation strategies and methodologies.
Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities is a huge plus.
Experience with program management software and tools are a plus.
Proficient in MS Office applications (Word, Excel, PowerPoint, and Outlook).
Experience with data aggregation, processing and analysis software and tools and/or statistical software applications is a plus.
Experience with Data Historian and Distributed Control Systems is a plus.
Experience working with external parties and/or cross-functional teams.
Experience interfacing with clients.
Possess strong verbal/written communication skills and ability to influence at all levels.
Ability to think strategically and to translate strategy into actions.
Ability to prioritize tasks in a highly dynamic environment.
Employee is required to sit or stand for long periods of time while fully gowned in a grade B attire. |
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