Process Engineer

Process Engineer (Downstream Processing)

Location: Leiden

Working mode: 3 days on-site and 2 WFH

Duration: 12 months

Hours: 40 hours per week

Imagine your next project driving process engineering and continuous improvement within downstream processing, where your expertise in troubleshooting, compliance, and operational efficiency directly impacts life-saving medical innovations.

A developing to experienced support individual contributor who maintains, and improves production processes, while managing supportive processes and ensuring continuous improvement. Works collaboratively with management and operations to drive decisions regarding process engineering and methods, to produce comprehensive processes, operational efficiencies, and alignment with production goals. Escalate issues and risks as necessary. Demonstrates effective communication skills with both internal and external customers. Maintains high standards of professionalism, efficiency, personal communication, discretion, and independent judgment.

This is a dynamic role requiring flexibility with changing priorities and strong communication skills. The role focus covers end-to-end downstream processing systems, troubleshooting, deviations, and process improvement, with a workload split of approximately 70% office/desk-based and 30% shop floor (including GEMBA walks and operational support), working closely with operations teams and senior process engineers.

roles and responsibilities

• Demonstrates Johnson & Johnson’s Leadership Imperatives and Credo in day-to-day interactions with team.

• Is required to understand and comply with the Code of Business Conduct, Company policies and laws that govern their activities.

• Perform related duties as assigned by supervisor.

• Support the introduction of new production processes and/or systems.

• Regularly reviews deliverables and verify adherence to Good Manufacturing Practices (GMP) and applicable internal and external regulations and procedures.

• Ensure smooth operation of existing production processes, addressing any issues that arise to maintain product quality, productivity and minimize downtime.

• Continuously evaluate and improve production processes to optimize performance, reduce costs, and increase efficiency to meet overall production goals.

• Monitor and continuously assess the process to ensure it operates within validated and regulatory limits, achieving expected output/yield, and collaborate with cross-functional teams to develop strategies and implement improvements to minimize downtime and losses.

• Ensure adequate documentation for production process, including Standard Operating Procedures (SOPs), Work Instructions and Master Batch Records.

• Conduct periodic Quality Risk Assessments and periodic document review.

• Subject Matter Expert responsible for product impact assessments, representative for non-conformances and owning CAPA’s.

• Contribute to change control implementation and non-conformance investigations.

• Oversee the performance qualification (PQ) of processes and equipment and, if necessary, supports the validation of supporting processes.

• Apply expertise in process to support escalations that cannot be resolved in the first line.

• Conduct Gemba walks and view the process performed by the manufacturing operators and leads sustainable improvements to enhance safety, quality, reliability, cost, and scheduling.

• Takes ownership of personal training and ensures that all required training is understood and completed on time.

• Enhance a culture of belonging through trusting, diverse, & inclusive relationships.

• Support developing training programs specific to the process.

• Subject Matter Expert on process related topics during inspection and audits.

• Representative of the Operations unit, following FPX methodology as core or extended team member.

• Works with the Asset Team to align equipment-related changes.

• Engage in Continuous Process Verification (CPV) and annual product review (APR) activities by providing information and performing additional research as required.

how to succeed

• A relevant HBO degree with 3 years relevant experience, or a Bachelor's or Master's degree.

• 3 to 5 years of relevant downstream process engineering experience.

• English B2 language level is required (Fluent English; Dutch is beneficial but not mandatory).

• Intermediate level computer proficiency for MS office, routine level for data analysis, and specialist level for business applications.

• Positive attitude, proactivity, decisive, and organized with an ability to work individually and in a team.

• Stress-resistant, continues to work calmly under all circumstances.

• High degree of accuracy and quality attitude.

• Flexible, can deal with changing priorities.

• Shows accountability by proactively addressing issues and taking responsibility for outcomes.

• Analytical thinking: ability and dealing with complexity, asking questions, using data, using information and identify gaps and root causes of issues and think out of the box to develop a solution.

• Prioritize tasks effectively to meet deadlines and ensure timely delivery.

• Maintains effective alignment with stakeholders and establishes meaningful connections with customers.

• Practices giving and receiving transparent and constructive feedback, learn from mistakes, and drive initiatives to achieve organizational and personal development goals.

• Coordinates team initiatives by providing clear direction and ensuring effective collaboration within the team.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert.

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 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”.