Scientist

SRG

Newbridge

On-site

GBP 36,000 - 43,000

Full time

9 days ago
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Job summary

SRG in Deeside is seeking a Scientist II – Physical Testing to support medical devices product development. The role involves designing and performing physical tests, documenting results and ensuring GMP/GLP/GDP compliance, with a focus on data integrity.

You will develop test methods, analyse data with statistics, and prepare validation reports while coordinating with R&D. The position is on-site for a 12-month contract, requiring 2–3 years lab experience and strong communication.

Qualifications

  • Bachelor’s Degree in a relevant science-related discipline (e.g., biological sciences).
  • 2-3 years in a working laboratory environment, preferably in Medical Devices/Pharmaceutical industry.
  • Good written and verbal communication skills.
  • Working knowledge of FDA/ISO regulatory requirements for Quality Systems and GMP guidelines.

Responsibilities

  • Design, plan and execute Physical Testing in support of R&D activities and base business projects.
  • Development and validation of new Physical Testing methods.
  • Author validation protocols, reports and technical documents for medical devices/pharmaceutical products.
  • Independently analyse and interpret data through statistical analysis.
  • Prepare and present internal presentations to communicate findings.
  • Ensure data integrity and timely, GLP-compliant reporting.
  • Assist in lab method/procedural revisions and change control activities.
  • Support daily laboratory activities including equipment maintenance and sample handling.

Skills

Physical testing
Laboratory experience
Communication skills
MS Office
Regulatory compliance
Statistics (Minitab)
Safety in lab

Education

Bachelor's degree

Tools

Minitab

Job description

Scientist II – Physical Testing
Location – Deeside
Fully on site
Pay rate - £142.32 per day
Contract Length – 12 months

A Scientist II in the physical Testing Department supports the product development process for medical devices. Scientist II’s should have good understanding of the important of physical testing in ensuring the safety, efficacy, and quality of medical devices. Scientists are responsible for conducting various tests and experiments to assess the physical properties of medical devices. Scientists will generate, document and analyse data in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP). Scientist II’s should also be able to use their knowledge and experience to develop test methods based on recognised industry standards bespoke test methods that satisfy the requirements of our products. Scientists should be detail orientated, able to work on multiple projects and adapt to changes, with good problem-solving skills and strong communication are essential.

Key Responsibilities:
  • Working within a controlled ISO 13485 and ISO 9001 laboratory quality system and in accordance with GxP procedures.
  • Design, plan and execute Physical Testing in support of R&D activities and base business projects in accordance with applicable procedures and guidelines.
  • Development and validation of new Physical Testing methods.
  • Estimating the resources and time required to conduct an experiment and monitoring performance to ensure targets are met.
  • Author validation protocols, reports and technical documents for medical devices/pharmaceutical products.
  • Independently analyse and interpret data through statistical analysis.
  • Prepare and present internal presentations to present findings of the laboratory.
  • Effective organisation of assigned workload; ensures integrity of all data generated and timely/accurate provision of results to GLP standards.
  • Accurate recording and analysis of laboratory data in accordance with good documentation practices.
  • Perform detailed laboratory investigations to determine the root cause analysis of atypical and out of specification results, apply corrective and preventative actions and author concise investigation reports.
  • Assist in laboratory test method/procedural revisions.
  • Ensures laboratory compliance with cGMP regulations and SOP’s/TD’s.
  • Involvement in change control activities and associated actions.
  • Support laboratory daily activities such as laboratory housekeeping, equipment maintenance and calibration, solution preparation, consumable stock replenishment, shipping samples, scanning documentation, logging of samples etc.
Skills & Experience:
  • 2-3 years in a working laboratory environment, with Medical Devices/Pharmaceutical Industry is preferred.
  • Good written and verbal communication skills.
  • Broad understanding of physical testing.
  • Good working knowledge of Microsoft Office, specifically Word and Excel.
  • Familiarity with safe working in a laboratory environment. Experience in a working laboratory environment, within Medical Devices/Pharmaceutical Industry is preferred.
  • Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and GMP Guidelines and Regulation.
  • A detailed understanding of common statistical analysis and experience with MiniTab desirable.
Qualifications/Education:

Bachelor’s Degree in a relevant science-related discipline, i.e., biological sciences

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