Position Title: Engineering - Process Engineer
Work Location: Warren, NJ
Assignment Duration: 6 Months
Work Schedule: M-F Standard business hours (Some flexibility to work over weekend as per the project need)
Work Arrangement: 100% Onsite
Position Summary: The Manufacturing Sciences and Technology Engineer supports the production of personalized cell therapy products for global clinical trials.
Background & Context:

• 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.

Key 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 Regulatory.
• Create an environment of teamwork, open communication, and a sense of urgency.
• Support the change agent in promoting flexibility, creativity, and accountability.
• Support organizational strategic goals and objectives that are linked to the overall company strategy.
• Drive strong collaboration within the plant and across the network.
• Build trust and effective relationships with peers and stakeholders.
• Deliver results through timely and quality decision making and advice.
• Promote a mindset of continuous improvement, problem solving, and prevention.
• Lead project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management.

Qualification & Experience:

• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities.
• Bachelor’s Degree required in Engineering or Related Discipline (advanced degree is preferred).
• 2 or more years of manufacturing support or related experience in the biopharmaceutical industry.

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $50.00/hr.