Process Engineer
Process Engineer
Posted on :
09-08-2025
Employer Active
1 Vacancy
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Job Description
Job Description:
A. Physical /Mental Demands:
- Experience in cell therapy/biologic/vaccine manufacturing support tech transfer and validation.
- 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.
- 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.
- Bachelors degree required.
- Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs).
- Experience in GMP setting and CAR-T cell therapy.
- Sponsor and support the change initiatives and the implementation of process improvement initiatives.
- Support Clinical Production Activities.
- Basic knowledge of cGMPs 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.
- Experience with the start-up validation and licensure of new biopharmaceutical manufacturing facilities.
- Bachelors 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.
A. 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.
- Lighting and temperature are adequate and there are no abnormal conditions caused by noise dust etc.
- This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
- This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Employment Type
Full-time
Key Skills
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