Microbiologist

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

This position is within the Laboratory Products Group (LPG) Laboratory Plastics Essentials division located in Newport.

DESCRIPTION

Join Thermo Fisher Scientific as a Microbiologist and contribute to global healthcare and scientific this role youll ensure compliance with GMP standards European regulations and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams youll implement continuous improvement initiatives conduct investigations and maintain our lab quality management systems that enable our mission of making the world healthier cleaner and safer.

Key responsibilities include:

• Oversee all microbiological testing of products including bioburden and endotoxin testing according to established procedures
• Manage laboratory function including staff chemical inventory and budgetary spend
• Manage environmental monitoring of controlled areas including Class 7 Cleanrooms ensuring compliance with ISO 14644
• Manage ongoing testing of product families and ensure all product validations are maintained in compliance with ISO 11137
• Ensure cleaning of controlled areas is carried out in accordance with procedures and train staff in correct cleaning techniques and documentation
• Serve as GMP champion for the site conducting periodic GMP training for all staff and monitoring ongoing compliance
• Liaise with customers as required on all microbiological issues
• Ensure all test methods are reviewed regularly and comply with relevant standards and best practices

REQUIREMENTS

• Bachelors degree with preferred 2 years of experience in pharmaceutical/biotech manufacturing quality assurance or related GMP environment
• Preferred Fields of Study: Biology Chemistry Life Sciences or related scientific field
• Knowledge of cGMP regulations ISO standards (9001/13485) and international regulatory requirements
• Knowledge/Experience with ISO 11137 sterilization standards
• Knowledge/Experience of ISO 14644 for cleanroom classification and monitoring
• Experience with microbiological testing methods including bioburden and endotoxin testing
• Experience with environmental monitoring programs
• Experience with quality management systems and documentation (TrackWise Oracle or equivalent)
• Experience in deviation investigations CAPA change control and root cause analysis
• Proficient in Microsoft Office suite and quality management software systems
• Technical writing and documentation skills
• Analytical and problem-solving abilities
• Clear verbal and written communication skills
• Ability to work independently and collaboratively in cross-functional teams
• Experience conducting internal audits and supporting external regulatory inspections
• Ability to work in cleanroom environments and follow gowning procedures where required
• Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs