Senior Scientist, Process Validation
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Supply Chain ManufacturingJob Sub Function:
Manufacturing DeploymentJob Category:
ProfessionalAll Job Posting Locations:
Mechelen Antwerp BelgiumJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.
Learn more at are searching for the best talent for a Senior Scientist Process Validation to be based in Antwerp Belgium.
Our Global Focus in Advanced Therapies
Advanced therapy medicinal products (ATMPs) including CAR-T and viral vector-based treatments represent a transformative approach to patient care. As a global organization we strive to harmonize validation strategies ensuring consistency compliance and innovation throughout our manufacturing network.
The Process Validation Center of Excellence
The CoE provides strategic leadership for validation activities and governance standards to drive accountability across partners. We define standard processes drive harmonization and enable technology adoption to ensure robust validated processes that meet regulatory expectations and deliver life-changing therapies to patients worldwide.
Role Summary
The Senior Scientist serves as a key member of the global Life Cycle Management team responsible for developing implementing and governing validation strategies across the Advanced Therapies network. This role focuses on global alignment standardization of validation approaches and strategic oversight of Tech Transfer PPQ campaigns CPV programs and digital readiness. This role partners closely with regional MSAT R&D Quality Regulatory and Engineering teams to ensure consistent compliant and innovative validation practices globally.
Operational Excellence & Governance
Define and maintain global Validation Master Plans and governance frameworks for ATMP processes.
Drive global implementation of risk-based validation approaches aligned with ICH Q8/Q9/Q10 Annex 15 and FDA/EMA guidance.
Author harmonized validation standards and templates across the global network.
Provide strategic oversight for PPQ campaigns implemented at multiple sites ensuring consistency and compliance.
Support global CPV strategy apply data analytics statistical tools and risk management principles to evaluate process capability and drive data-informed decisions.
Support lifecycle improvement initiatives and evaluate digital tools for process monitoring.
Partner with regional and site teams to assess validation readiness for new technologies and platforms.
Support and author regulatory submissions with globally aligned validation documentation and strategies.
Cross-Functional Leadership & Communication
Act as an inspiring leader mentoring teams and influencing global validation policy and innovation.
Facilitate collaboration and communicate program goals progress risks and results to senior leadership and technical teams with clarity and influence.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s)
United States -Requisition Number: R-048421
Belgium - Requisition Number: R- 049802
Ireland - Requisitions Number: R-049778
Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.
Required Qualifications:
Education:
Bachelors degree in biology biotechnology or related scientific field is required; advanced degree or equivalent experience preferred.
Skills & Experience:
7 years proven experience within a regulated biologics or pharma industry
Experience in global process validation strategy governance and regulatory compliance for ATMPs.
Strong understanding of risk-based validation principles and Health Authority expectations.
Demonstrate the ability to work effectively in cross-functional environment and influence global teams
Preferred Qualifications:
Prior experience in cell culture or viral vector commercial manufacturing is highly desired.
Knowledge in statical process control and analytical data modeling.
Experience in digital solution implementation and deployment.
Knowledge in data management platforms and data governance
Other Requirements:
International travel to partner sites and global meetings up to 20% of the time. Flexibility to work remotely when not travelling.
Language requirements fluency in English required; additional languages preferred.
Required Skills:
Preferred Skills:
Agile Manufacturing Business Process Design Coaching Communication Critical Thinking Good Manufacturing Practices (GMP) Innovation Manufacturing Engineering Manufacturing Flow Management Manufacturing Processes Plant Operations Proactive Behavior Problem Solving Product Development Lifecycle Production Operations Profit and Loss Responsibility Robotic Automation Structural Fabrication SustainabilityRequired Experience:
Senior IC
Key Skills
- Laboratory Experience
- Mammalian Cell Culture
- Biochemistry
- Assays
- Protein Purification
- Research Experience
- Next Generation Sequencing
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Flow Cytometry
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
