QC Microbiology Technician

2 weeks ago

Livingston West Lothian, United Kingdom Valneva SE Full time

Valneva is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Our focused pipeline includes the world’s first vaccine against the chikungunya virus, the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

Please find a link to our corporate video for a quick insight into Valneva

The successful applicant will be expected to undertake microbiological tasks and analysis for the release and monitoring of facilities, raw materials, intermediate and final product samples according to defined procedures and protocols, in accordance with regulatory requirements

  • Execute microbiological procedures for testing of raw materials, intermediate products and final product samples, according to defined SOPs and protocols.
  • Perform environmental monitoring of cleanrooms and supporting areas as required, to support manufacturing processes and Facility Contamination Control (FCC).
  • Conduct all activities in a careful and safe manner and in full compliance with HSE requirements.
  • Ensure that equipment, facilities and materials used in the QC laboratories comply with defined standards.
  • Adhere to 5S working practices. Identify and implement areas for continuous improvement and escalate to Line Manager.
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to line manager.
  • Maintain all QC systems, databases, logs and support the generation of QC trend data.
  • Be accountable for QC areas including laboratories being clean, tidy and well organised and in a state of continuous inspection readiness.
  • Ensure that all required training is current in procedures performed and operate in compliance with regulatory requirements.
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within a team setting.
  • Undertake any other duties in accordance with company requirements.
  • Undertake shift work and/or support activities that require to be performed out of normal business hours, when requested, to support business priorities.

Experience

  • Biological sciences degree qualification is required.
  • Knowledge of GMP guidelines and regulatory body requirements.
  • Experience of microbiological methods in a production-focused environment including but not limited to; Total Viable Count, Bacterial Endotoxin, Environmental monitoring, Microbial Identification by Gram-stain.
  • Minimum of 2 Years relevant Industry Experience.
  • Experience using a GxP Quality Management Systems.
  • Experience of working to deadlines and managing conflicting priorities.

Required Skills

  • Ability to organise, deliver planned schedules and work across QC, Process Development and QA.
  • Experience of writing QMS documentation, e.g. SOPs, Deviations, Change Controls, CAPA desired.
  • Experience operating with all Microsoft Office software.
  • Excellent time management skills.
  • Capable of working on multiple activities concurrently.
  • Good communication skills and ability to communicate across multiple departments at all levels.
  • Ability to contribute effectively to successful teamwork, and work independently and manage own workload when required.
  • Stock Options
  • Employee Assistance Programme
  • Gym membership OR fitness allowance
  • Free Fruit
  • Many others included
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