Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Location/Division Specific Information
The Groningen site is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (phase 1, 2 and 3) and commercial production.
How will you make an impact?
As a Manufacturing Systems Investigator, you are a system and support specialist, working closely with the entire Operations and Quality department, as well as all other departments across the site. In this growth role, a Manufacturing Systems Investigator promotes consistency, continuous improvement and compliance with Global/Site quality and business requirements.
The Manufacturing Systems Investigator team is responsible for Batch ownership, Quality systems management within the Operations department, and working closely with Operational Excellence to be driving continuous improvement projects and deliver high quality product to our customers worldwide.
What will you do?
As a Manufacturing Systems Principle Investigator you are a Quality Systems Specialists that drives Quality Systems within the Operations department. Key deliverables include:
Batch Ownership: As batch owners, you are responsible for maintaining oversight and knowledge of the entire production process performed on site. You will be responsible for ensuring every batch you own is on track for disposition deadlines.
Management and ownership of Deviations
Lead and assist Deviation Investigations
Implementation and execution of SMART CAPAs and Effectiveness Checks
Assist in Audits/Inspections
Training and facilitation of Quality Systems
Coordinate and facilitate meetings with cross-functional groups (operations, quality, laboratory, compliance, validation, and engineering personnel).
By monitoring individual manufactured batches and associated quality records the Manufacturing Systems team use trending to detect and prevent future issues, identify areas for improvement and evaluate site performance.
What do you have?
You hold a Master’s degree in a scientific field: Bio engineering, Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology
2 years of relevant experience in pharmaceutical manufacturing.
Fluent in English (written and spoken language)
Good knowledge and working in cGMP environment.
Good knowledge of regulatory requirements
Strong problem analysis/solving and troubleshooting abilities
Strong communication skills
Strong project management skills
You have an analytical and critical mindset
You are cooperative, disciplined, driven and reliable.