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

7555-Janssen Pharmaceutica NV Legal Entity; Geel; On-site; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being support

Health insurance

Service awards

Job summary

Johnson & Johnson is seeking a dynamic MST Validation Engineer to lead cleaning, sterilization, and process validations at our DP-Pilot Plant. You will work within the Pharmaceutical Supply & Engineering Sciences organization to support base validations and project work.

Ideal candidates hold MSc/PhD in chemistry or pharma-related fields, with GMP exposure and strong collaboration skills to partner with QA, pilot-plant teams, and cross-functional partners in a fast-paced environment.

Qualifications

• MSc or PhD in chemistry, pharmaceutical sciences, (bio)chemical or mechanical engineering or related field; GMP/regulatory exposure preferred.
• Experience in GMP regulated pharmaceutical development/engineering is important.
• Fluency in English; Dutch helpful.

Responsibilities

• Accountability for cleaning validation and sterilization validation for the internal DP-Pilot Plant.
• Support base business validations and deliver on project validation requirements with a team.
• Lead validation strategies and interact with QA and pilot-plant teams.
• Collaborate across internal and external experts on validation activities.
• Maintain compliance with current regulatory requirements and J&J guidelines.

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/PhD in chemistry, pharma sciences, (bio)chemical or mechanical engineering, or related field

Tools

SAP Product Lifecycle Management

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

Your role

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). 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).

Your responsibilities (initial)

• 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).

Your responsibilities (continued)

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, Annex1) 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.

Required 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

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

Pay

The anticipated base pay range for this position is: €60,000.00 - €96,255.00

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.
• We also 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.

Our Credo

Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities.