Senior Engineer Process Validation MSAT

Senior Engineer Process Validation MSAT

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 https://www.jnj.com.

Job Function: Supply Chain Engineering

Job Sub Function: Process Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Geel, Antwerp, Belgium

Job Description:

Supervisor: Karina Versyck (Lead Process and Cleaning Validation MSAT)

The Chemical Production facility in Geel (Belgium) is the largest site of Synthetics Manufacturing (SM) of Drug Substances and Drug Product Intermediates at Johnson & Johnson Innovative Medicine (J&J IM). Furthermore, it is the Launch & Grow site for J&J IM SM. Within the Manufacturing Science and Technology (MSAT) department in Geel, the Staff Engineer Process Validation has a focus on Life Cycle Process Validation (LCPV) and on support of Real-Time-Release applications in manufacturing.

Key Responsibilities:

• Lead process validation activities for New Product Introductions (NPI) and commercial products, in close collaboration with planning department, technical launch integrator, process engineer, production department, quality assurance, and quality control.
• Set up Process Performance Qualification (PPQ) plans for new PPQ-studies preserving production feasibility and efficiency.
• Develop statistical or risk-based sampling plans, interpret test results, and perform statistical evaluations.
• Draw up and maintain Validation Master Plan and other validation documents.
• Lead the execution of Life Cycle Process Validation.
• Perform gate keeping of proposed changes, assess impact, and complete LCPV actions as assigned.
• Prepare and update LCPV documents, procedures, and maintain related database.
• Train new co-workers in LCPV work process and maintain the training.
• Provide support for trending of model performance for local Real-Time-Release models in manufacturing, giving local support to end-users, and providing recommendations for the RTR app roadmap.
• Be the Local Process Owner of the Process Validation Quality System.
• Be the domain authority for LCPV Geel as member or lead in local and global teams e.g. SM Drug Substance LCPV Community of Practice.
• Be the J&J IM Point of Contact for third parties working on LCPV and CPV for Geel, and follow-up and track deliverables and performance.
• Reduce deviations and continuously improve the process validation work processes according to standards of quality, safety, health, environment, and cost.
• Apply 'Management of Change' principles for optimizations and changes.
• Build up and demonstrate excellent expertise in process validation work processes, and profound knowledge of the equipment, production environment, and process management systems, supporting MSAT knowledge building and the site mission as Launch & Growth Site.

Minimum Qualification:

• Master's Degree (University) bioscience engineering, chemical engineering, chemistry, biomedical sciences, or pharmacy with minimum 5 years work experience in life sciences manufacturing.
• Certified or willing to be trained/certified as statistical subject matter expert.
• Experience in process validation, real-time-release applications, and/or Synthetics Drug Substances manufacturing is highly valued.
• Combining scientific and administrative accuracy with good social skills.
• Strong quality mentality with knowledge of Quality & Compliance and GMP/regulatory requirements.
• Ability to work under pressure, handling conflicting interests, having a good sense of prioritization of tasks, and handling time accordingly.
• Highly team-oriented, able to interact at different levels of the organization.
• Proficient in Dutch and English (spoken and written).

Required Skills:

Preferred Skills: Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection