Work with us to innovate and enrich people's lives through science and technology. Our colleagues across the globe are passionate about caring for our diverse mix of people, customers, patients, and planet.
The Role
We are seeking a Laboratory Analyst to join our analytical laboratory project team. The successful candidate will work on various activities, including test method validation, equipment validation, training, and development of laboratory processes and standard operating procedures (SOPs).
Duties:
* Maintain adherence to all company environmental health and safety (EHS) guidelines and procedures, actively contributing to laboratory safety initiatives.
* Develop and validate laboratory test methods.
* Collaborate on the preparation and execution of the Project Validation Master Plan, ensuring compliance with relevant regulatory and 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 laboratory staff and develop onboarding plans for future analysts within the area.
* Lead analytical method development/troubleshooting for the project laboratory groups.
* Review laboratory data, ensuring accuracy for all relevant products within the project scope.
* Validate laboratory equipment, software, spreadsheets, and methods.
* Perform validation, release, and non-routine testing as required.
* Support site commercialization readiness.
* Maintain lab fitness for audits.
* Ensure compliance of laboratory projects with applicable quality, regulatory, and Pharmacopeia requirements, as well as divisional and corporate requirements.
* Work within Filtration 2.0 laboratory calibration and preventative maintenance system.
* Provide technical support to F2.0 functional groups as required.
* Ensure laboratory project timelines are adhered to and communicated with the laboratory supervisor.
* Evaluate and ensure protocols, reports, test methods, SOPs, and other relevant documentation are drafted and approved prior to use.
* Complete laboratory investigations in a timely manner, following site procedures.
* Provide full support to laboratory colleagues during investigations, utilizing standard root cause analysis tools.
* 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 according to procedures.
* Order, receive, and control laboratory chemicals, reagents, and consumables.
* Investigate quality and safety issues using root cause analysis methodology and implement corrective and preventative actions.
Requirements
Bachelor of Science degree in Analytical Chemistry, Microbiology, or related field.
A minimum of 2 years of practical experience in Medical Device/Pharmaceutical environment. Experience in technical transfers is an advantage.
Strong background in laboratory techniques, experience with LIMS, Trackwise, MES, and SAP is beneficial. Lean Six Sigma Training (Yellow Belt, Blue Belt, etc.) is also an advantage.
This role may involve international travel, sometimes for extended periods.
We offer a dynamic work environment, opportunities for career growth, and a chance to work with a diverse group of talented individuals. We celebrate all dimensions of diversity and believe 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.