BE - Process System Engineer

Janssen Pharmaceutica is recruiting for the Manufacturing Excellence CAR-T EMEA organization, located in Ghent Belgium.

Your responsibilities and your Impact:

The Manufacturing Excellence CAR-T EMEA organization is an organization which provides and supports a high degree of assurance that specific processes will consistently produce and meets its pre-determined specifications by deploying process validation, process system engineering, data architecture and continuous process verification and process investigation.

The team drives process optimizations to enable seamless transition from clinical to commercial operations.

Key Responsibilities:

• 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.

Education and Experience Required for Role

Essential:

• An Masters degree in Engineering (Mechanical/ Electrical, Bio), or equal in Biomedical Sciences or Pharmacy is required

• A minimum of five (5) years of experience in process engineering or operations within an industrial manufacturing or regulated environment is preferred.

• Experience in a controlled pharmaceutical cleanroom environment under aseptic conditions is preferred.

Experience and Skills:

• 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

Other preferred skills:

• 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

• Ability to interact with all levels within the organization and build strong partnerships with Operations, Global Engineering and Quality

• Transparent, passionate, responsible and accountable, handle conflicting interests and take decisions

• Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly

• Problem solving skills and attitude

• Fluent in written and spoken English

• Fluent in written and spoken Dutch is a plus

Things to remember before applying for this role:

• We are looking to process the first round of applications within the next 2 working days.

• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application.

Questions

If you would like some additional information about the role please contact: bdardenn@its.jnj.com (please note that we do not accept applications via email).

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Belgium are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.