Johnson & Johnson Hiring for Process System engineer Job at Gent Full Time

• Will deploy the competence center for manufacturing equipment on cell therapy processes.
• Provides guidance and execution on aspects of design of experiments for manufacturing equipment
• Assure requalification of manufacturing equipment in case of improvements of post-investigation activities.
• Write, review and approval of equipment related characterization plans, protocols and reports upfront of equipment qualification.
• Will take the lead in introducing new technologies for specific type of equipment, sharing global platform competences and/or introducing best practices from other manufacturing facilities.
• Perform upgrades to and support the implementation of new process equipment, instruments and systems
• Implement or propose alterations, modifications, or replacement of existing equipment and systems to improve process reliability and reduce overall equipment lifecycle costs and process downtime
• Identify and provide support for the implementation of new and innovative cost & quality improvement initiatives for the successful development of business opportunities as required
• Support the creation of new practices, policies and procedures (e.g., SOPs, Work Instructions, etc.) pertaining to Operations, Engineering and Maintenance to enhance the performance of the business
• Support process driven quality events including (but not limited to): Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, CAPAs, Root Cause Analysis and FMEA
• Participate in system and process improvement / optimization projects
• Reviews technical reports and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology
• Support process investigations with accurate knowlegde and competences.

• A good understanding of technical installations, process equipment, facilities and computerized systems within an industrial manufacturing or regulated environment. Experience in the Pharmaceutical, Biotechnology, Cell Therapy, human plasma derived products or related industry is required.
• Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations
• Strong analytical, problem solving and critical thinking skills
• Ability to identify/remediate gaps in processes, equipment, facilities and business systems and to troubleshoot problems for highly technical equipment.
• Strong working knowledge of current Good Manufacturing Practices (cGMP). Experienced in working with validated and qualified process equipment and systems, and associated documentation.

– Project Management – provide timely and accurate reporting on project activities to peers and leadership

• Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment. Entrepreneur mentality preferable.
• Available for other duties and demonstrate willingness to learn new skills as required