Scientific Principal Engineer

jj

Beerse

Sur place

EUR 80 000 - 138 000

Plein temps

Il y a 13 jours
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Avantages offerts par ce poste

On-site sports facilities
Health programs
Family benefits

Résumé du poste

Johnson & Johnson in Beerse, Belgium is seeking a Principal Engineer for Manufacturing Sciences & Technology (MST) to manage clinical manufacturing activities across internal DP-Pilot Plant and external CMOs. You will lead cross-functional teams in scale-up, tech-transfer, and process optimization, ensuring right-first-time manufacturing for DP material.

The role emphasizes project leadership, collaboration, and regulatory compliance in a truly global environment with the DP development team and

Qualifications

  • MSc or PhD in chemistry, pharmaceutical sciences, (bio)chemical or mechanical engineering with at least 10 years in GMP pharmaceutical development/engineering.
  • Experience with oral solid dosage, liquids and/or parenteral product manufacturing and related tech like spray drying, extrusion, and continuous manufacturing is desirable.
  • Experience in regulated environments (FDA GMP) is important; familiarity with equipment requirements and processes is beneficial.
  • Strong organizational/coordination skills with risk-management knowledge.
  • Excellent collaboration and influencing skills across multiple groups and internal teams.
  • Technical expertise plus growing project management capability; openness to advanced data sciences/tools.
  • Understanding of qualification, validation, and change management in pharma.
  • Proactive, technically strong communication in a global setting; ability to work independently under timelines.
  • Fluency in English; Dutch is a helpful additional skill.
  • Willingness to travel up to 5% of the time.

Responsabilités

  • Lead and coordinate DP development activities in internal DP-Pilot Plant and external CMO network.
  • Represent PSES in drug product development and clinical supply chain teams.
  • Drive pilot-plant readiness and scale-up/tech-transfer preparations for DP processes.
  • Own project budgets and manage cross-functional project milestones.
  • Evolve workflows for early development pilot-plant tech transfers, manufacturing, and business processes.
  • Endorse manufacturing instructions and specifications with internal departments.
  • Cultivate pharma manufacturing science expertise across platforms through cross-functional collaboration.
  • Introduce clinical manufacturing activities in DP pilot plant and ensure right-first-time manufacturing.

Connaissances

English proficiency
Project management
Collaboration
Process engineering
Quality systems

Formation

MSc or PhD in chemistry/pharmaceutical sciences/engineering

Outils

SAP Product Lifecycle Management

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: R&D Product Development

Job Sub Function: R&D Process Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Beerse, Antwerp, Belgium

Job Description:

Position: Principal Engineer – Manufacturing Sciences and Technology, Global Product Integration

At Johnson & Johnson, we’re on a mission to improve the lives of millions of patients around the globe. If you’re ready to be a pioneer in the development of innovative therapeutics, we want you to join us on this exciting journey! This role offers a unique opportunity for a dynamic Manufacturing Sciences & Technology Engineer to make a real impact.
About the Department

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 a Principal Engineer, global product integration in the MST team. You will be accountable for the management of clinical manufacturing activities for synthetic-molecule drug products from the internal Drug Product Pilot Plant (DP-Pilot Plant) and the external CMO network. 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.

Your role

As a Manufacturing Sciences & Technology (MST) Principal 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) and across the external network, 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 / CMO manufacturing readiness,

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

  • Account ownership of 1 or more external CMO’s

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.

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.

Taking ownership of dedicated project budget to fulfill financial commitments.

  • Dynamic Project Leadership and Coordination

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.

  • Transformative Process Improvement and Optimization

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.

Your Qualifications
  • MSc or PhD in chemistry, pharmaceutical sciences, (bio)chemical or mechanical engineering, or other discipline within pharmaceutical/biotechnology sciences with at least 10 years experience in GMP regulated pharmaceutical development/engineering area.

  • Familiarity with oral solid dosage, liquid, and/or parenteral product manufacturing, 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 stone’s 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 you’re ready to take the next step in your career and make a meaningful impact, we want to hear from you! #DPDS

Required Skills:

Preferred Skills:

Agile Decision Making, Coaching, Crisis Management, Critical Thinking, Disruptive Innovations, Emerging Technologies, Engineering, Organizing, Process Control, Process Engineering, Process Improvements, Product Costing, Program Management, Project Schedule, Research and Development, SAP Product Lifecycle Management, Tactical Planning, Technical Research, Technical Writing

The anticipated base pay range for this position is:

€79,800.00 - €137,770.00

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 location’s 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.

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