Scientist II (12-Month Contract)
Job Title: Scientist II
Location: Deeside
Contract Duration: 12 Months
PAYE Rate: £142.32 per day
Position Overview
The Scientist II is responsible for performing analytical testing on existing and new medical devices, skincare products, and raw materials in accordance with approved protocols, Standard Operating Procedures (SOPs), Operating Control Instructions (OCIs), and Technical Documents (TDs). The role supports product claims generation, analytical method development, validation activities, and laboratory operations while maintaining compliance with applicable quality standards and regulatory requirements.
The successful candidate will contribute to research and development projects, ensure high standards of laboratory compliance, and provide technical expertise across a range of analytical techniques and equipment.
Key Responsibilities
Analytical Testing & Data Management
- Conduct analytical testing of medical devices, skincare products, and raw materials in line with approved protocols and procedures.
- Analyse, interpret, document, and report laboratory data in accordance with GMP and GLP requirements.
- Compile laboratory results and generate technical reports to support product development and business objectives.
- Perform technical data reviews for analytical testing activities.
- Carry out technical approval checks for reports generated by the Analytical function.
Method Development & Validation
- Design, develop, optimise, and validate analytical methods for new products, raw materials, and analytical techniques.
- Support planned and ad-hoc analytical testing and method development projects.
- Execute method validation activities to ensure suitability for intended use.
- Troubleshoot analytical methods and laboratory issues to drive continuous improvement.
Laboratory Compliance & Quality
- Maintain compliance with ISO 13485 and ISO 9001 quality standards through adherence to GLP/GMP-compliant procedures.
- Prepare and manage quality documentation, including:
- Change Control Records
- Non-Conformance Reports
- Out-of-Specification (OOS) Investigations
- Participate in laboratory investigations and root cause analysis activities with appropriate supervision.
- Support internal and external audits by providing accurate and timely information.
Equipment & Laboratory Operations
- Maintain, calibrate, document, and update quality records for laboratory equipment.
- Act as a technical expert for designated analytical instrumentation, particularly HPLC systems.
- Operate and maintain a broad range of analytical equipment, including:
- HPLC
- FTIR
- ICP-MS
- Balances
- Pipettes
- Other analytical instrumentation
- Coordinate with external vendors regarding equipment servicing, maintenance, calibration, and service contracts.
- Monitor laboratory stock levels and initiate reordering of consumables, chemicals, and reagents as required.
Documentation & Systems
- Author and maintain SOPs, OCIs, and Technical Documents.
- Submit controlled documentation through the Electronic Data Management System (EDMS) for review and approval.
- Utilise software packages for data management, analysis, and reporting, including:
- Microsoft Word
- Microsoft Excel
- SAP
- Waters Empower
- ChemStation
- MassHunter
- Minitab
Training & Collaboration
- Train and mentor new or less experienced laboratory personnel on equipment operation and testing procedures.
- Support other R&D teams through laboratory testing and technical expertise when required.
- Collaborate effectively with Scientists, Senior Scientists, Team Leaders, and laboratory management to achieve project goals.
- Participate actively in team activities and continuous improvement initiatives.
Continuous Improvement & Safety
- Maintain a safe laboratory working environment and report near misses, hazards, and safety concerns.
- Implement and support Lean and 6S initiatives within the Analytical Laboratory.
- Drive improvements to analytical processes, testing methods, and laboratory procedures.
- Ensure the correct handling and disposal of chemicals, reagents, and solvents in accordance with site and environmental procedures.
Skills & Experience
Essential
- Bachelor's degree (BSc) or equivalent in a scientific discipline.
- Strong understanding of laboratory health and safety practices.
- Experience with analytical chemistry techniques and laboratory operations.
- Ability to follow and comply with SOPs, OCIs, and Technical Documents.
- Experience in analytical method validation.
- Proficiency in Microsoft Office applications, particularly Word and Excel.
- Strong data interpretation, reporting, and problem-solving skills.
- Ability to work effectively within a regulated environment and manage multiple priorities.
Preferred
- Degree in Analytical Chemistry or a related scientific discipline.
- 3-4 years' experience within the Medical Device, Pharmaceutical, or related regulated industry in an R&D or Product Development environment.
- Experience operating advanced analytical instruments such as HPLC, FTIR, and ICP-MS.
- Working knowledge of FDA regulations, ICH guidelines, Quality Systems, and GMP requirements.
- Experience with laboratory data systems and analytical software platforms including Empower, ChemStation, MassHunter, and Minitab.
Qualifications
Required
- BSc degree or equivalent in a scientific discipline.