Scientific Experienced Engineer

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Position: Experienced Engineer Manufacturing Sciences and Technology Global Product Integration (temp role 3 years)

Drug Product Research & Development (DPRD) is part of the Pharmaceutical Development organization and plays a crucial role in delivering medicines to our patients during the development phase of a new product. Within this organisation the Pharmaceutical Supply & Engineering Sciences team (PSES) is responsible for the upscaling and fine tuning of formulation and processes which result in the successful clinical manufacturing of new Drug Product (DP). Our activities include all in-house and outsourced planning manufacturing and distribution of clinical supplies through a global network. We supply more than 60.000 patients in more than 300 clinical trials every year.

For our DP Pilot plant in Beerse Antwerp Belgium we are looking for an Experienced Engineer global product integration in the MST team. You will be accountable for the management and execution of clinical manufacturing activities for synthetic-molecule drug products with a primary focus on the internal Drug Product Pilot Plant (DP-Pilot Plant). This role covers processes for oral solids liquids and parenteral applications across small-scale and pilot-scale operations and the use of innovative pilot-plant manufacturing platforms.

As a Manufacturing Sciences & Technology (MST) Experienced Engineer you will be a core member of the Pharmaceutical Supply and Engineering Sciences organization.

The MST engineer is responsible for successful introduction and follow-up of clinical manufacturing activities in the Drug Product (DP)-Pilot Plant (PP) being the PSES representative in the drug product development team and clinical supply chain team.

Working within an international setting and in cross functional teams the MST engineer is responsible for and supports:

• Lean and right first-time process introduction in the internal pilot plant
• Pilot-plant manufacturing readiness
• Potential scale-up & tech-transfer preparation of drug product processes from the PP to commercial manufacturing facilities from a (clinical) manufacturing perspective.

Technologies span over processes for oral solids liquids and parenteral applications ranging from small scale to pilot-scale processes e.g. from a single punch tablet press to a continuous manufacturing line and e.g. vial filling for parenteral production.

As a key player of our PSES team you will help shape the future of drug product formulation and process development. Your responsibilities will include:

• Dynamic Project Leadership and Coordination

Act as PSES representative in Drug Product Development and Clinical Supply Chain project teams assuring and coordinating DP clinical readiness activities.

Serve as the primary internal point of contact within development and pilot-plant operations and team members fostering collaborative relationships to internalize new manufacturing processes that ensure right-first-time outcomes while optimizing workflows.

Proactively identify lead and navigate project critical path milestones adeptly managing risks and implementing innovative corrective actions to sustain robust process development and successful clinical manufacturing.

• Transformative Process Improvement and Optimization

Drive the evolution of existing workflows by addressing challenges head-on and uncovering opportunities to enhance early development pilot-plant tech transfers manufacturing and business processes within an international team and on a global scale.

Establish review and endorse manufacturing instructions and specifications collaborating effectively with internal departments and pilot-plant teams.

• Innovation-Focused Expertise - Development and Collaboration for Success

Cultivate manufacturing sciences expertise across diverse manufacturing platforms through cross-functional collaboration with development teams and subject matter experts ensuring alignment with latest industry standards.

Take ownership of the successful introduction of clinical manufacturing activities in the internal pilot plant acting as a key collaborator and partner for the DP development team contributing to advancements in pharmaceutical manufacturing and assuring right-first-time manufacturing of clinical drug product material.

• MSc or PhD in chemistry pharmaceutical sciences (bio)chemical or mechanical engineering or other discipline within pharmaceutical/biotechnology sciences with at least 2 years experience in GMP regulated pharmaceutical development/engineering area.
• Strong/basic to profound knowledge of parenteral manufacturing activities (e.g. sterile handling aseptic filling vial/syringe workflows) is a key advantage. Familiarity with oral solid dosage liquid and/or parenteral products as well as conventional and some innovative manufacturing technologies like spray drying extrusion and continuous manufacturing. Basic understanding of process analytical technologies is desirable.
• Experience working in regulated environments (e.g. FDA standards and general GMP guidelines) is important. Awareness of relevant internal and external regulations regarding equipment requirements and processes through literature workshops and training is beneficial.
• Good organizational and coordination skills with knowledge of risk management. Able to search literature and utilize other resources effectively to apply and advance knowledge practically.
• Good collaboration and influencing skills to partner effectively at different levels and across multiple groups. Able to establish working relationships with internal teams(focus on internal cross-functional partners and pilot-plant teams).
• Technical expertise is valued alongside developing project management skills. A willingness to explore advanced data sciences and related tools is a plus.
• Understanding of qualification validation and change management systems in the pharmaceutical industry is an advantage.
• Proactive and strong communication skills are essential for working in a global and dynamic setting. Ability to work independently under challenging timelines while maintaining a focus on quality is important.
• Fluency in English both written and spoken is required. Proficiency in Dutch is a helpful additional skill.
• Willingness to travel up to 5% of the time.

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.