Scientist - Physical Testing

Position Overview

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.

• Working within a controlled ISO 13485 and ISO 9001 Laboratory quality system and in accordance with GLP/GMP procedures.
• Design, plan and execute physical testing in support of R&D activities and base business projects in accordance with applicable procedures and guidelines.
• Involvement in the development and validation of new physical testing methods.
• Effective organization 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 of atypical and out of specification results, apply corrective and preventative actions and author concise investigation reports.
• Author validation protocols, reports and technical documents for medical devices / pharmaceutical products.
• Assist in laboratory test method/procedural revisions.
• Responsible for standard laboratory routines, equipment calibration, maintenance replenishment etc. Ensures lab compliance with applicable cGMP regulations and SOPs/TD’s.
• Involvement in change control activities and associated actions.
• Perform basic statistical analysis of test data.
• Support laboratory admin activities e.g. shipping samples, scanning, logging of samples etc.
• Support minor calibration activities.
• Solution preparation.

• Good written and verbal communication skills.
• 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 (ISO 13485:2016, ISO 9001:2000, 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.

• Working in a laboratory environment with exposure to biological agents, chemicals and reagents – Training will be provided.
• Competent in the disposal of chemicals and reagents in accordance with site and local environmental procedures – Training will be provided.
• Health and Safety at Work etc. Act 1974
• The Management of Health and Safety at Work Regulations 1999.

Some flexibility in hours required due to working in an international company with colleagues in different time zones.

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Thank you.