Process Engineer- CAR T Manufacturing (Onsite- Warren, NJ) - Stage 4 Solutions : Job Details

Process Engineer- CAR T Manufacturing (Onsite- Warren, NJ)Process Engineer- CAR T Manufacturing (Onsite- Warren, NJ)

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Process Engineer- CAR T Manufacturing (Onsite- Warren, NJ)We are seeking a Process Engineer- CAR T Manufacturing for a global pharmaceutical client. You will be responsible for supporting the production of personalized cell therapy products for global clinical trials. Collaborates with SMEs from the Development Group, Global MSAT Group, Supply Chain Group, Manufacturing Group, and Quality Group while providing technical support for the resolution of process deviations, the evaluation and implementation of process changes and continuous improvement support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.This is a 40-hour per-week, 6-month contract (extensions possible), 100% onsite role in Warren, NJ.M-F Standard business hours (Some flexibility to work over weekend as per the project need)This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.Responsibilities

• Ensure safe and compliant cGMP operations;
• Maintain permanent inspection readiness and actively support regulatory inspections.
• Interface with regulatory authorities as required to support Manufacturing Operations audits.
• Foster a culture of compliance and strong environmental, health, and safety performance.
• Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
• Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements
• Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)
• Sponsor and support the change initiatives and the implementation of process improvement initiatives. Support Clinical Production Activities;
• Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
• Continuously monitor, anticipate and permanently resolve issues that may arise during production.
• Interface with operators and serve as process SME. Learn the procedures, analytics and document any known sensitivity.
• Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements
• Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs
• Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records)
• Interact with other teams including Validation, Development, Operations, QA and Regulator

Requirements

• 2+ years of manufacturing support or related experience in the biopharmaceutical industry
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
• Experience in cell therapy/biologic/vaccine manufacturing support, tech transfer, and validation.
• Bachelor's Degree required in Engineering or Related Discipline (advanced degree is preferred)

Please submit your resume to our network at (please apply to the Process Engineer- CAR T Manufacturing (Onsite- Warren, NJ) role).Please feel free to forward this project opening to others who may be interested.Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.Compensation: $50/hr. - $52.64/hr.

Seniority level

• Seniority levelEntry level

Employment type

• Employment typeContract

Job function

• Job functionManagement and Manufacturing
• IndustriesBusiness Consulting and Services

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