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

Johnson & Johnson Co.; Beerse; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Johnson & Johnson is seeking a dynamic MST Validation Engineer for the DP Pilot Plant in Beerse, Belgium. You will lead cleaning and sterilization validation activities, ensuring compliance with GMP and regulatory standards, and work in a cross-functional team to support process development and clinical manufacturing.

In this role, you will own validation activities, contribute to continuous improvement, and coordinate with QA, internal experts, and regulatory bodies to ensure right-first-time

Qualifications

• MSc or PhD in chemistry, pharmaceutical sciences, (bio)chemical or mechanical engineering, or related field with GMP experience.
• Experience in GMP regulated pharmaceutical development/engineering.
• Familiarity with FDA standards/Annex 1 is beneficial.

Responsabilités

• Own and support validation activities per the validation master plan.
• Provide and implement validation requirements across projects.
• Lead validation strategies and improvements.
• Collaborate with QA and subject-matter experts for compliant, right-first-time manufacturing.
• Interface with regulatory audits and external partners as needed.

Connaissances

Validation engineering

Cross-functional teamwork

Regulatory audits

Process optimization

Formation

MSc or PhD in chemistry/pharmaceutical sciences

Description du poste

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.

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 g