Scientific Engineer – Manufacturing Sciences and Technology, Validation (fixed for 3 years))

Biopharma Careers; Antwerpen; Hybrid; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Health programs

Well-being reimbursement

Job summary

Johnson & Johnson is seeking a MST Validation Engineer to drive cleaning and sterilization validation for the DP-Pilot Plant in Beerse, Antwerp, Belgium. You will work in a global, cross-functional team to ensure compliant, right‑first‑time manufacturing of clinical drug product materials.

You will contribute to validation strategy, risk management, and process improvements while collaborating with QA, regulatory, and external experts in a fast-paced pharmaceutical setting.

Qualifications

• MSc or PhD in chemistry, pharmaceutical sciences, (bio)chemical or mechanical engineering with GMP/pharma experience.
• Experience in regulated environments (GMP, FDA guidelines) is beneficial.

Responsibilities

• Lead cleaning and sterilization validation activities for the DP-Pilot Plant.
• Support validation master plan and audits in cross-functional teams.
• Collaborate with QA and external partners to ensure right‑first‑time manufacturing.
• Develop and implement validation strategies and process improvements.
• Serve as process owner for validated operations and regulatory submissions.

Skills

Analytical reasoning

Coaching

Computerized equipment

Emerging technologies

Engineering

Gemba Kaizen

Mechanical equipment

Process control

Process oriented

Product improvements

Purchasing

R&D

SAP PLM

Situational awareness

Teamwork

Technical research

Technologically savvy

Education

MSc or PhD in chemistry, pharmaceutical sciences, (bio)chemical or mechanical engineering

Job description

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:

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 MST Validation 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 organization, 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 Engineer, cleaning and sterilization validation in the MST team. You will be accountable for the cleaning validation, sterilization validation (and process validation when applicable) for the internal Drug Product Pilot Plant (DP-Pilot Plant).

Your role

As a cleaning and sterilization validation engineer you will be a core member of the Pharmaceutical Supply and Engineering Sciences organization.

You are responsible for successfully supporting the base business validations and delivering on project work covering validation aspects together with a team of validation engineers in the Drug Product (DP)-Pilot Plant (PP)

Working within an international setting and in cross functional teams, the cleaning and sterilization validation engineer is responsible for and supports:

Accountability for base business verification/validation activities according to validation master plan

Provide and execute on validation requirements in portfolio and technical projects

Process owner for certain validation processes and spokesperson in regulatory and/or customer audits

Implementation of optimizations and defining new/updated validation strategies

Establish relationships with a network of internal and external experts on validation (CoP, ...)

All the mentioned assignments should be performed in accordance with:

Current regulatory requirements

J&J guidelines

Technologies span over equipment for manufacturing oral solids, liquids and parenteral applications, together with supporting equipment for cleaning (parts washer, CIP) and for sterilization (autoclave, SIP).

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:

Transformative Process Improvement and Optimization: Drive the evolution of existing workflows by addressing challenges head‑on and uncovering opportunities to improve way of working

Innovation-Focused Expertise - Development and Collaboration for Success: Cultivate expertise through cross-functional collaboration with QA and subject matter experts, ensuring alignment with latest industry standards.

Take ownership of the validation approach for the clinical manufacturing activities in the internal pilot plant, acting as a key collaborator and partner for the clinical operational department, 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 preferably a few years of experience in GMP regulated pharmaceutical development/engineering area.

Experience working in regulated environments (e.g., FDA standards, general GMP guidelines, Annex 1) is important. Awareness of relevant guideline and regulation regarding validation and sterile manufacturing 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 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.

Understanding of qualification, validation, and change management systems in the pharmaceutical industry is an advantage.

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.

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.

#DPDS

Required Skills:

Preferred Skills:

Analytical Reasoning, Coaching, Computerized Equipment Skills, Emerging Technologies, Engineering, Gemba Kaizen, Mechanical Equipments, Process Control, Process Oriented, Product Improvements, Purchasing, Research and Development, SAP Product Lifecycle Management, Situational Awareness, Teamwork, Technical Research, Technologically Savvy

The anticipated base pay range for this position is:

€60,000.00 - €96,255.00

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.