Process Engineer

Pay Range: $48 - $52
Description

Engineer I, CAR T Clinical Manufacturing Sciences and Technology
Onsite !
M-F Standard business hours ( Some flexibility to work over weekend as per the project need)
Experience in cell therapy/biologic/vaccine manufacturing support, tech transfer, and validation

Purpose and Product of position:

• The Manufacturing Sciences and Technology Engineer Clinical CAR-T Engineering and Technology Support is 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.

Required Competencies: Knowledge, Skills, And Abilities

• Basic knowledge of cGMP s and multi-national biopharmaceutical/cell therapy regulations
• Basic knowledge of facility/clean room design, process, equipment, automation, and validation
• Intermediate strong verbal/written communication skills and ability to influence at all levels
• Intermediate ability to think strategically and to translate strategy into actions
• Intermediate ability to prioritize and provide clear direction to team members in a highly dynamic environment
• Basic knowledge of quality by design and risk management
• Basic experience with Operational Excellence and Lean Manufacturing

Duties And 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

Display Leadership Qualities.

• 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

Education And 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

Working Conditions:
Physical /mental demands:

• Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time.

Environmental conditions:

• Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.