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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimaginable with us.
The Role
Reporting to the Filtration 2.0 Laboratory Supervisor, the Laboratory Analyst is a key member of the analytical laboratory project team and working on analytical project requirements through analytical laboratory transfer and commercialization in a new manufacturing facility in Blarney, Cork. The Analyst will work on several different activities including test method validation, equipment validation, training and development laboratory process and SOP development.
Duties:
• Adhering to all company EHS guidelines and procedures with proactive involvement in laboratory safety initiatives.
• Development and validation of laboratory test methods.
• Collaborate on the preparation and execution of the Project Validation Master Plan ensuring it is compliant with the relevant regulatory and Merck Millipore quality standards. • Prepare validation and other related documentation, including protocols, SOPs, management procedures, etc.
• Execute protocols and compile reports generated from validation activities identified in the validation master plan.
• Train on laboratory procedures and develop onboarding plans for future analysts within the area.
• Lead analytical method development/troubleshooting for the project laboratory groups.
• Review of laboratory data where required, ensuring accuracy for all relevant product within the project scope.
• Validation of laboratory equipment, software, spreadsheets and methods.
• Perform validation, release, and non-routine testing as required.
• Support site commercialization readiness.
• Maintain lab fitness for audits.
• Ensuring compliance of the laboratory projects to all applicable quality, regulatory and Pharmacopeia requirements as well as all relevant divisional and corporate requirements.
• Work within Filtration 2.0 laboratory calibration and preventative maintenance system.
• Provide technical support to all F2.0 functional groups as required.
• Ensure laboratory project timelines are adhered to, and timelines are communicated with the laboratory supervisor.
• Ensure protocols, reports, test methods, SOPs and all other relevant documentation are drafted and approved prior to use.
• Ensure all laboratory investigations are completed in a timely manner and in accordance with site procedures.
• Ensure laboratory colleagues have full support for laboratory investigations and that standard root cause analysis tools are utilised.
• Contribute to risk mitigation initiatives such as FEMAs and risk assessments.
• Identify and participate in Continuous Improvement initiatives.
• Control, issue and maintain laboratory documentation. Archive laboratory data, logbooks and samples in accordance with procedures.
• Order, receive and control laboratory chemicals, reagents and consumables.
• Thorough investigation of quality and safety issues using root cause analysis methodology and implementation of robust corrective and preventative actions.
• Other duties as required.
Who You Are
B.Sc. in Analytical Chemistry, Microbiology or related discipline.
A minimum of 2 years practical work experience in Medical Device/Pharmaceutical environment. Experience in technical transfers would be an advantage.
Strong background laboratory techniques
Experience in LIMS, Trackwise, MES and SAP an advantage
Experience in test method or equipment validation Lean Six Sigma Training (Yellow Belt, Blue Belt, etc.) an advantage
Thorough, practical and persistent self-starter
Strong motivation
Good communication skills
Good computer literacy
Strong problem solving, organisational & time management skills
This role may involve travel abroad, in some cases for extended periods
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
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