Microbiology Technician

MUST BE BASED IN THE UK TO BE ELIGIBLE.

Location: Barnard Castle UK
Working model: Onsite
Reports to: Micro Manager
Start date: ASAP

Overview
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.

Role Overview
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).

Key Responsibilities

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 Manager/Technical Leader.
• Take responsibility for decisions made during production activities.
• Train production-area staff and Engineering in aseptic techniques.
• Ensure training records are updated.
• Maintain awareness of all relevant assessments including EHS COSHH manual handling DSE and company health and safety requirements.
• Maintain knowledge of company and regulatory specifications for tests carried out within the area.
• Plan and organise own activities.
• Share knowledge and experience with relevant areas.
• Co-ordinate production-area shutdowns from a microbiological perspective.
• Escalate serious quality issues to management in a timely manner.

Planning and Organising:

• Prepare and maintain stock cultures for use in the laboratory for example bacterial spore suspensions and cultures for identification.
• Prepare and publish reports as directed by the Team Manager.
• Liaise directly with Production/Quality Assurance (QA) as required.
• Efficiently schedule media supply services to biological laboratories.
• Plan and organise area shutdowns and attend meetings.
• Plan and organise long-term projects/NPI activities.
• Prioritise weekly workload to achieve lead times and maintain stock control.
• Ensure good housekeeping standards are maintained at all times.
• Ensure high levels of GMP standards are maintained at all times.
• Be actively involved in potency and technical support investigations.
• Plan and organise process and operator simulation trials.

Continuous Improvement:

• Be involved in investigations and projects across all production areas/departments.
• Provide direct support to major site projects.
• Participate in continuous improvement activities by providing direct support to major projects across the site.
• Be involved in operational excellence activities within the department and throughout production.
• Complete actions relating to 5S Kaizen Gemba and Lean Sigma activities as required.

Systems and Data Responsibilities:

• Store data and carry out trend analysis.
• Enter data onto company computer systems.
• Review batch documentation according to current SOPs.
• Interpret results and record and complete data efficiently and accurately.

Equipment and Processes:

• Operate sterilising equipment including autoclaves and ovens for media preparation.
• Use equipment involved in the preparation of microbiological media.
• Use equipment involved in the manufacture of sterile agar plates.
• Take daily temperature recordings for incubators and fridges.
• Ensure all equipment used is in a safe and operational condition and where applicable report and resolve any failures.
• In certain roles be involved in equipment calibration and maintenance.

Environment:

• Clean and dispose of used/contaminated equipment.
• Remove and replace pre-filters and HEPA filters.
• Carry out smoke integrity testing of HEPA filters.
• Carry out non-viable particulate classification of clean rooms/LF cabinets.
• Measure air rate room volume and differential pressure.
• Determine airflow patterns.
• Analyse non-condensable gases.
• Work within plant rooms and air-handling units.
• Ensure facilities comply with the environmental monitoring rationale.
• Work in aseptic areas.
• Undertake physically and mentally demanding work during shutdown periods including moving equipment and carrying out manual tasks.

Skills Experience & Qualifications
We are looking for professionals with these required skills to achieve our goals:

Knowledge and Experience:

• Extensive knowledge of manufacturing and filling processes gathered through extended knowledge and experience.
• Good working knowledge of GMP and GLP.
• Minimum of five GCSEs.
• Up to two years experience working within microbiology.
• Good process understanding of SOPs for all facilities across the site.
• Ability to gain significant knowledge of changing procedures and their principles.
• Knowledge of company and regulatory specifications for tests carried out within the area.
• Knowledge of computers.

Training and Licences:

• External courses required for more specialised activities.
• Licences required to perform activities within any aseptic facility.
• Required to gain Aseptic Area Entry and Operator licences.

Systems Knowledge:

• LIMS.
• e-Doc.
• Databases including Spec.
• QA drive providing access to all quality files.
• Oracle Discover.
• Documentation and SOP data reviews.
• Microsoft Word and Excel.
• CPM Parmagraph System.

Required Equipment Experience:

• Particulate counters.
• Autoclaves.
• Photometers.
• Air samplers.
• KQCL Endotoxin.
• Annometers.
• CPM systems.
• Ovens including Bac Lab.
• Balometers.
• Smoke equipment.
• TOC analyser.
• MD8 samplers.
• Digital cameras.
• Production Bosch tunnels.
• Cassella samplers.
• Chessels.
• Filling machines.
• Royco systems.

What We Value In You

• Ability to work to high GMP and GLP standards.
• Strong attention to detail and commitment to microbiological compliance.
• Effective communication and stakeholder engagement skills.
• Strong problem-solving and investigation capability.
• Ability to plan organise and prioritise workloads.
• Commitment to continuous improvement and operational excellence.
• Collaborative approach with production quality engineering and laboratory teams.

Why GSK

Uniting science technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose to unite science technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas (infectious diseases HIV respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome valued and included. Where they can keep growing and look after their wellbeing. So if you share our ambition join us at this exciting moment in our journey to get Ahead Together.

Inclusion at GSK

GSK is an EqualOpportunity/AffirmativeAction Employer. All qualified applicants will receive equal consideration for employment without regard to race color national origin religion sex pregnancy marital status sexual orientation gender identity/expression age disability genetic information military service covered/protected veteran status or any other federal state or local protected class.

If you need any adjustments in the recruitment process please get in touch with our Recruitment team() to further discuss this today.

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