Scientist II - Microbiology - 1 year contract in Shotton

Job Overview: Scientist II in the microbiology laboratory in the Global Testing Laboratories. Responsible for providing scientific and technical support to the development of new products. This includes method development, validation and testing. Ensures that all work performed in the microbiology lab conforms to internal procedures, reflects applicable regulations/guidelines and meets industry best practice.

Responsibilities:

• Working within a controlled ISO13485 laboratory quality system and in accordance with GLP/GMP compliant procedures.
• Perform routine microbiological tests to support the development of new medical device products.
• Development and validation of new microbiological assays.
• Accurate recording and analysis of laboratory data in accordance with good documentation practices.
• Writes validation protocols, reports and technical documents.
• Writes laboratory test methods and procedural revisions.
• Perform routine review of laboratory bench books/data, logbooks, equipment records; verifies and validates spreadsheets.
• Training of staff in microbial techniques and procedures.
• Responsible for standard laboratory routines, equipment calibration, maintenance, and replenishment.
• Preparation and maintenance of microbial stock cultures.
• Ensure compliance with quality control and laboratory processes and procedures; write non‑conformance and change control reports when required.
• Perform detailed laboratory investigations to determine the root cause for atypical and out‑of‑specification results, apply corrective and preventive actions and concise report investigations.
• Write COSHH and risk assessments for laboratory procedures.
• Apply an understanding of the role of microbiological testing within the product development process, particularly as it applies to the development of Medical Devices and Pharmaceuticals.
• Demonstrate good microbiological and problem‑solving skills and an understanding of the steps involved in initiating and completing a variety of microbiological tasks to support key R&D projects.
• Execute experiments accurately, effectively and in a timely manner, reporting progress to senior microbiology staff.
• Excellent oral and written communication skills.
• Use own initiative while working as part of a team.
• Handle multiple tasks simultaneously.
• Proactive and flexible in adapting to a changing environment and ability to balance multiple, competing priorities to meet objectives.
• Highly motivated, possessing excellent personal attributes as well as being a flexible team member willing to take on a wide variety of tasks.
• Adopt a practical, methodical, and flexible approach to working.
• Work effectively and communicate in cross‑functional teams, building cooperative working relationships.

Qualifications:

• Degree qualified, ideally in Microbiology, Biology or a similar related discipline.
• 3+ years of experience in a working microbiology laboratory environment, preferably within a Medical Device or Pharmaceutical Industry.
• Knowledge and understanding of compliance with FDA and European regulations relating to quality systems (ISO13485:2016, FDA 21 CFR part 820) and GMP Guidelines and Regulations.
• Good working knowledge of Microsoft Office, particularly Word and Excel.

Working Conditions: Laboratory/Office Environment. Working in a laboratory environment with exposure to biological agents, chemicals and reagents.