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The Scientist II in the Physical Testing Department supports the product development process for medical devices by conducting physical testing to ensure product safety, efficacy, and quality. The role involves generating, analysing, and documenting data in compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Documentation Practice (GDP). Scientist II's are expected to apply scientific knowledge and practical laboratory experience to develop, validate, and execute physical test methods based on recognised industry standards and bespoke product requirements. The role requires strong attention to detail, effective workload management across multiple projects, adaptability to change, and excellent problem‑solving and communication skills.
Job Responsibility:
Operate within a controlled ISO 13485 and ISO 9001 laboratory quality system
Ensure compliance with GxP, cGMP, SOPs and Technical Documents (TDs)
Maintain data integrity and ensure accurate, timely reporting to GLP standards
Participate in change control activities and associated actions
Design, plan and execute physical testing activities to support R&D and base business projects
Develop and validate new physical testing methods in line with industry standards
Estimate resource and time requirements for experiments and monitor performance to ensure targets are met
Assist with laboratory test method and procedural revisions
Independently analyse and interpret test data using statistical analysis tools
Author and technically approve validation protocols, reports, benchbooks, and technical documentation
Accurately record laboratory data in accordance with GDP requirements
Prepare and deliver internal presentations to communicate laboratory findings
Conduct detailed laboratory investigations into atypical or out-of-specification (OOS) results
Perform root cause analysis and implement corrective and preventative actions (CAPA)
Author clear, concise investigation reports
Support daily laboratory activities, including: Housekeeping, Equipment maintenance and calibration, Solution preparation, Consumable stock replenishment, Sample shipping and logging, Document scanning and filing
Requirements:
2-3 years' experience working in a laboratory environment
Broad understanding of physical testing techniques
Good written and verbal communication skills
Strong organisational skills and attention to detail
Good working knowledge of Microsoft Word and Excel
Understanding of safe working practices in a laboratory environment
Bachelor's Degree in a relevant science-related discipline (e.g. biological sciences)
Nice to have:
Experience within the Medical Devices or Pharmaceutical industry
Working knowledge of FDA and European quality regulations, including: ISO 13485:2016, ISO 9001, FDA 21 CFR Part 820
Knowledge and experience of GMP guidelines and regulations
Statistical analysis experience, with Minitab desirable