Senior Lab Technician - Microbiology, Sterility and Lungworm

Job Description

Position: Senior Lab Technician

Location: Milton Keynes
Department: Quality Control - Microbiological/Sterility Testing Laboratory

Purpose of role:

To provide technical and practical expertise for Microbiology and Sterility test methods to QC labs in the UK and liaise with other sites. To assist different functions on site for investigations, troubleshooting, change and CAPA implementation in relation to aseptic manufacture and monitoring. This role also involves support in testing of finished products and intermediates in accordance with GMP, dossier and relevant pharmacopoeia requirements.

Key Accountabilities and Duties:

1. To perform and oversee testing of all samples submitted to the micro and sterility department (including EM, water, intermediate and finished products) in accordance with GMP, dossier, quality guidelines and where relevant, as per pharmacopoeia requirements (testing includes Bioburdens, Lungworm, plate reading, sterility testing, growth promotion and Inactivation’s).
2. Training of new staff and ongoing training of staff in new or improved methods. Ensure training documents are kept up to date.
3. Identifies and facilitates Continuous Improvement opportunities which will improve productivity or result in cost savings.
4. Drive change management for introduction of new/improved methods and validation of new equipment and biomaterials.
5. Chair Environmental monitoring meetings and author Environmental monitoring trend reports.
6. Release of batches in accordance with LROT and LTA, escalating any potential effect to supply.
7. Provide the required data for the Product Quality Reviews, as required.
8. Update SOP's and Specs ensuring they are current and relevant.
9. SAP - ensure timely completion of results in SAP and up to date specifications for microbiology lab tests.
10. Investigations
    • To lead complex investigations for out of specification and out of trend test results. Finding root causes and raise appropriate CAPA actions. Ability to lead these as cross-functional investigations, when required.
    • Assist lab leads to ensure successful CAPA completion and verification including training of staff in new/improved test methods.
11. Ensure QMS commitments and timelines such as CAPA’s, change controls and deviations are adhered to.
12. Production Support - Offer support to Production for manufacturing issues relating to QC testing.
13. Health and safety representative for QC:
    • Participate in departmental safety meetings.
    • To qualify as COSHH, Manual handling and Risk Assessor.
14. Promote safety within the laboratory areas, by carrying out safety observations, ensuring correct signage and maintaining COSHH documentation to prevent or reduce unnecessary exposure to hazardous substances.
15. Deputise for the team leader to attend capacity and production tier meetings, as required.
16. Support the team leader to prepare the schedule for the Microbiology/Sterility Lab and laboratory work, including arranging cover for weekends and holidays.
17. Assist Procurement and QA with changes relating to external suppliers of test materials and other critical consumables used for testing.

Closing date for application: 27/01/2025

Qualifications:

Degree in Microbiology or related Biological Sciences - Science Degree

Skills and Ability:

Project management, proficient in use of Microsoft Office especially Excel and Word. Good protocol, hypothesis and report writing skills. Ability to troubleshoot and resolve issues. Able to communicate at all levels and across all functions. Ability to communicate concise technical information with clarity. Good time management in a high flow through laboratory. Flexible approach to changing priorities. Attention to detail.

Requirements:

Microbiology/Sterility lab experience, GMP Compliance, SAP/LIMS knowledge, experience with excellent understanding of testing within a laboratory environment, laboratory investigations, method and equipment validation, method transfers.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully:
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 01/28/2025

*A job posting is effective until 11:59:59 PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R331208