Scientist I - Infusion Care

ConvaTec Inc; Shotton; Hybrid; GBP 25,000 - 35,000; Full time

Job summary

A leading medical device company is seeking a Scientist I in the Physical Testing Department in Shotton, UK. The role involves conducting tests to ensure the safety and quality of medical devices while adhering to regulatory standards. Ideal candidates will hold a relevant Bachelor's degree and possess strong communication and analytical skills. This role is primarily onsite with occasional remote work flexibility.

Qualifications

• Good understanding of physical testing for ensuring safety and quality.
• Experience in a working laboratory environment preferred.
• Graduate/entry level with familiarity of laboratory safety.

Responsibilities

• Conduct tests to assess the physical properties of medical devices.
• Author validation protocols, reports, and technical documents.
• Perform detailed investigations to determine root cause analysis.

Skills

Good written and verbal communication skills

Microsoft Office (Word and Excel)

Compliance with FDA and European regulations

Statistical analysis (MiniTab)

Education

Bachelor's Degree in a relevant science-related discipline

Job description

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.
• Perform basic statistical analysis of test data.
• 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.

A Scientist I in the Physical Testing Department supports the product development process for medical devices. Research Assistants should have a good understanding of the importance 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). Scientists should be detail-oriented, able to work on multiple projects and adapt to changes, with good problem‑solving skills and strong communication are essential., Graduate/entry level. Familiarity with safe working in a laboratory environment. Experience in a working laboratory environment, within Medical Devices / Pharmaceutical Industry is preferred.

Skills & Qualifications

• Good written and verbal communication skills.
• Good working knowledge of Microsoft Office, specifically Word and Excel.
• 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.
• Bachelor's Degree in a relevant science-related discipline, i.e., biological sciences.

Principal Contacts & Purpose of Contact

• Scientific and Technology laboratory members - collaborative work, problem solving, data discussion.
• Project team representatives - collaborative work, problem solving, delivery of results.

This position is based in Deeside (UK) working within an office and laboratory environment. This is an onsite position with the opportunity to occasionally remote work as an when agreed in advance with their manager.