What are the responsibilities and job description for the Process Engineer position at Joulé?
Job Title: Process Engineer
Location: Warren, NJ
Type: Contract
Compensation: $41.45 - $52.5 hourly
Full Job Description:
The Process Engineer is responsible for supporting the production of personalized cell therapy products for global clinical trials. Collaborates with SMEs 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.
RESPONSIBILITIES
Location: Warren, NJ
Type: Contract
Compensation: $41.45 - $52.5 hourly
Full Job Description:
The Process Engineer is responsible for supporting the production of personalized cell therapy products for global clinical trials. Collaborates with SMEs 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.
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
REQUIREMENTS- 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
- Basic knowledge of cGMPs and multi-national biopharmaceutical/cell therapy regulations
- Basic knowledge of facility/clean room design, process, equipment, automation, and validation
- Basic knowledge of quality by design and risk management
- Basic experience with Operational Excellence and Lean Manufacturing
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #558-Scientific
- Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
Salary : $41 - $53