Microbiology Technician

MUST BE BASED IN THE UK TO BE ELIGIBLE.

MUST BE BASED IN THE UK TO BE ELIGIBLE.

Location: Barnard Castle, UK

Working model: Onsite

Reports to: Micro Manager

Start date: ASAP

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade. Our R&D division is at the forefront of this mission, dedicated to the discovery and development of groundbreaking vaccines and medicines. We are transforming the landscape of medical research by integrating cutting-edge science and technology and harnessing the power of genetics and new data.

By fostering a collaborative environment that unites the talents of our people, we are revolutionizing R&D to pre-empt and defeat diseases. Join us in our commitment to uniting science, technology, and talent to get ahead of disease together.

GSK are looking for a Microbiology Technician to join the team in Barnard Castle. This person will perform a wide range of biologically activities related to the environmental control and cross contamination control of microbiological compliance of all facilities on site (Steriles, Liquids, Topicals and Cephs).

Main Tasks:

• Actively perform routine monitoring programmes in all production areas across the site whilst employing high standards of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
• Demonstrate good knowledge of regulatory requirements associated with any areas of specialism.
• Assist in the development of methodology for new or modified techniques and the preparation of written SOPs/methods.
• Receive, record and prepare samples within different areas.
• Write and issue reports and memos covering all aspects of the Process Monitoring Department.
• Work with direct supervision on and off the Barnard Castle site.
• Maintain aseptic practices and standards.
• Sample process waters for chemical, microbiological, endotoxin and particulate analysis.
• Complete batch release, ALE progression and IPN progression.

Occasional Tasks:

• Actively perform routine monitoring programmes within the areas as required.
• Carry out microbiological examination of raw materials, intermediates and non-sterile finished products.
• Carry out bacteriological identifications to species level.
• Perform microbiological preservative efficacy testing.
• Evaluate the bioburden of components and miscellaneous items.
• Perform D-value estimations on prepared spore suspensions.
• Perform microbial integrity tests of container/closure combinations.
• Package and transport agar plates.
• Perform aseptic filling simulation trials.
• Perform BET on product raw materials and water samples according to recognised lead times.
• Perform sterility and non-sterile testing on products.
• Perform potency estimations on products and raw materials.
• Perform area shutdown activities across the site.
• Publish reports to validate new equipment and areas.
• Plan and perform area process and operator qualification filling trials.
• Investigate adverse unplanned events.
• Perform chemical and particulate analysis of waters.
• Perform total organic carbon analysis of water.
• Carry out sampling following engineering intrusion into the water system.
• Validate, calibrate and maintain equipment.

Communication, Discussions and Presentations:

• Prepare quality reports, memos on area standards and emails.
• Discuss area problems and observations of operators with TMs and Production Co-ordinators.
• Deliver annual and ad hoc presentations on aseptic techniques.

Meetings and Stakeholder Communication:

• Plan and organise meetings, including listening, advising, persuading and influencing.

Communicate with the following:

• Own TM and Ops Manager.
• Production and OQ in all areas regarding quality matters.
• Engineering to complete any remedial actions arising from observations.
• NPI to plan activities associated with new products and product transfers.
• Fellow team members.
• SAU to prepare and perform 3 log 10 reduction work.
• External suppliers and quality validation contractors.
• Other GSK sites.

Problem Solving:

• Deal with day-to-day routine production quality issues and advise OQ and Production Co-ordinators on resolving issues.
• Discuss, agree and implement actions with other staff to form a solution to rectify problems.
• Investigate and document occurrences using the appropriate systems.
• Advise OQ on biological issues.

People Responsibility:

• Train junior staff in aspects of their work as specified by the Team…