Experienced Engineer – Manufacturing Sciences and Technology

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Position: Experienced Engineer Manufacturing Sciences and Technology

About the Department

Join the Global Pharmaceutical Product Development and Supply (PPDS) organization within the Therapeutics Development and Supply (TDS) team at Johnson & Johnson. Based in Beerse Antwerp Belgium our development centers span the US Asia and Europe driving the creation of cutting-edge pharmaceutical dosage forms.

Within PPDS we are looking for a Manufacturing Sciences & Technology Experienced Engineer in the Pharmaceutical Supply & Engineering Sciences (PSES) organisation located in Beerse Belgium. You will be accountable for the management and execution of early development 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 especially parenteral applications across small-scale and pilot-scale operations and the use of innovative pilot-plant manufacturing platforms.

Your Role

As a Manufacturing Sciences & Technology (MST) Experienced Engineer you will be a core member of the Pharmaceutical Supply and Engineering Sciences organization focused on early development in the internal pilot plant.

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 teams.

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

• Lean and right first-time process introduction during early development 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. syringe and vial filling lines 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:

• Potential scale-up & tech-transfer preparation of drug product processes from the PP to commercial manufacturing facilities from a (clinical) manufacturing perspective.

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.

• Potential scale-up & tech-transfer preparation of drug product processes from the PP to commercial manufacturing facilities from a (clinical) manufacturing perspective.

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.

• Potential scale-up & tech-transfer preparation of drug product processes from the PP to commercial manufacturing facilities from a (clinical) manufacturing perspective.

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.

Your Qualifications

• 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.

Our Offer

• Exciting Opportunities: Join an international and dynamic environment that promotes continuous learning and personal growth.

• Prime Location: Work at a site that encompasses all aspects of drug discovery and development just a stones throw from the vibrant city of Antwerp.

• Competitive Benefits: Enjoy a competitive salary on-site sports facilities health programs and family benefits that support your well-being.

• Inclusive Culture: Be part of a diverse team where your opinions are valued and a healthy work-life balance is a priority.

If youre ready to take the next step in your career and make a meaningful impact we want to hear from you!

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against on the basis of disability.

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