Specialist, Global Laboratory(m/w/x)

Anforderungen

• Bachelor’s degree in Natural Sciences or equivalent experience
• Minimum 3 years laboratory experience
• Operating state-of-the-art laboratory equipment
• Capability for laboratory work and microscopic evaluation (mandatory)
• Willingness to work in clean rooms (up to ISO 5)
• Fluent English & German (written and spoken)
• Collaboration and teamwork ability
• Advanced project management skills
• In-depth experimental skills for testing routines
• Strong project ownership mindset and motivation
• Excellent GMP compliant documentation skills
• Very good verbal and written communication skills
• Structured, independent work approach
• Thinking outside the box attitude
• Enjoyment of constructive technical discussions
• Solution-oriented, problem-solving mentality
• Willingness to learn and develop
• Flexibility for early/late shifts
• Good experimental and lab organizational skills
• Safe handling of measurement technologies/techniques
• Reliability, diligence, flexibility
• Microsoft Office software experience
• SAP and Minitab experience (plus)
• Ability to stand in laboratory environment
• Manual dexterity for operating tools/controls
• Mental skills: communication, decision-making, data interpretation, reading/writing

Aufgaben

• Develop methods for release testing and in-process control.
• Optimize methods for release testing and in-process control.
• Validate methods for release testing and in-process control.
• Collaborate with international teams to implement methods.
• Train users on developed methods.
• Support global laboratory teams.
• Contribute to global laboratory joint projects.
• Manage small and mid-size global projects.
• Plan small and mid-size projects.
• Track progress for small and mid-size projects.
• Report on small and mid-size projects.
• Communicate project updates for small and mid-size projects.
• Adhere to ESOPs, SOIs, and PFNBs.
• Ensure compliance with cGMP regulations.
• Author lab study protocols for method development.
• Execute lab study protocols for method development.
• Analyze experimental results independently.
• Author and execute validation protocols.
• Author and execute qualification protocols for computerized inspection systems.
• Author and execute PNRs.
• Author, execute, and document inter-laboratory studies.
• Train trainers on new global test methods and technologies.
• Perform literature searches on guidelines, publications, and equipment.
• Assist SMEs with deviation and out-of-spec investigations.
• Support the implementation of global change controls.
• Ensure compliance with safety regulations.

Berufserfahrung

Ausbildung

Sprachen

Tools & Technologien