Danaher Corporation Microbiologist in Newquay, United Kingdom
Danaher Company Description
Pall Corporation is a global leader in high-tech filtration, separation, and purification, serving the diverse needs of customers across the broad spectrum of life sciences and industry.
Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines, cell therapies and classic pharmaceuticals. Pall offers advanced medical technologies, which are often a patient’s last line of defense from dangerous pathogens. Pall’s food and beverage products provide critical protection from contaminants during various manufacturing steps.
Pall Industrial serves a diverse range of customers in the microelectronics, aerospace, fuels, petrochemical, chemical, automotive, and power generation industries. Pall is a key supplier to the innovative and demanding semiconductor and consumer electronics industries, and provides filtration products used in critical applications on commercial and military aerospace vehicles. Pall products are key to the reliability of industrial equipment. Pall’s engineered solutions help municipal and industrial customers address mounting water quality, scarcity and demand issues, and help energy companies maximize production and develop commercially successful next generation fuels.
Headquartered in Port Washington, New York, Pall has offices and plants throughout the world.
To learn more about Pall, please visitwww.pall.com/green.
OurQuality Assurance department islooking forward to welcome a
Microbiologist (Office based role) This is a unique opportunity to work for a large and dynamic global organisation.We are currently recruiting for a Microbiologist to join our established Quality Assurance Team at the Newquay plant. In this office based role you will providecompliance expertise and support related to microbiological product testing, product sterilization (initial validation and dose auditing) and clean room standards compliance and monitoring activities related to design, installation, in process control and personnel.
In this role the Microbiologist will: • Ensure compliant sterilization validation, revalidation and dose audit activity for Gamma and Ethylene Oxide product sterilization cycles at multiple sites • Ensure clean room environmental monitoring activities are complaint and monitored to establish priorities for compliance/improvement. • Ensure required practices and standards in the cleanrooms, site microbiology and subcontract laboratories are compliant and monitored to establish priorities for compliance/improvement • Coach the micro test team to maintain standards and make improvements • Ensure cleaning practices are validated, effective and up to date • Ensure compliant product development/transfer activities for sterile products • Audit sterilisation and external test laboratory sub contractors • Provide technical input to microbiology based product testing activities • Keep abreast of development of standards and best practice to ensure techniques and practices are kept up to date; recommend internal QMS/procedure changes as required • Preparation of miscellaneous documentation/reports. • Review and develop procedures relevant to role. • Conduct Manufacturing audits. • Performance management – monitoring of performance indicators relevant to the role. • Provide support to Quality Assurance Manager during external audits of Pall Newquay.
The successful applicant will have:
• Degree in Applied Biology, Microbiology or similar subject or equivalent experience. • Formal training and qualification in process improvement techniques would be an advantage. • ISO13485 auditing qualifications preferred.
Essential Previous Experience: • Experience of working within an ISO 13485/ Medical /Pharma/Food manufacturing environment. • Understanding and practical experience of Sterilization Standards and Quality Management Systems. • Able to investigate and solve complex issues • Knowledge of systems adopted within a regulated Manufacturing facility. • Experience of GMP/GLP. • Ability to communicate effectively both verbally and in written form with all levels of personnel. • Organisational skills.
Other knowledge & Key skills • Exhibit strong attention to detail and be results-oriented • Ability to organize and coordinate numerous activities concurrently. • Good mathematical skills • Team building and coaching skills and aptitude. • Knowledge of Quality tools and techniques. • Knowledge and experience of product environmental compliance would be an advantage
Other: • Interpersonal skills. • Keep up to date with Micro/GMP/GLP/Sterilisation standards and best practice evolution. • Logical, enquiring approach to work • Must be motivated and able to work to deadlines • Knowledge of and ability to use Microsoft Office applications including Excel, PowerPoint, Visio and Word. • Ability to work with minimum supervision, using own initiative, prioritising work as appropriate whilst maintaining a cross-functional team approach. • Able to make reasoned and objective decisions where necessary. • Able to work in a cleanroom environment. • Able to travel and work outside of normal hours when required.
Interested? Join the PALL Team!If you would like to explore this exciting opportunity further and find out more about the role we have to offer, please do not hesitate to contact us!**
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-United Kingdom-Cornwall-Newquay
Req ID: MED001527