Senior Engineer Process Validation MSAT
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Job Location:
Monthly Salary:
Posted on:
17 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 EngineeringJob Sub Function:
Process EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Geel Antwerp BelgiumJob Description:
Supervisor
Karina Versyck (Lead Process and Cleaning Validation MSAT)
Position Title
Senior Engineer Process Validation MSAT
The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
Essential Job Duties and Responsibilities
The Chemical Production facility in Geel (Belgium) is the largest site of Synthetics Manufacturing (SM) of Drug Substances and Drug Product Intermediates at Johnson & Johson 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
Masters 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 SelectionRequired Experience:
Senior IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
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
