Sr. Specialist, QC Microbiologist

Sr. Specialist, QC Microbiologist

Incyte

Yverdon, Switzerland

Job Summary (Primary function):

During the construction and QC laboratory startup phase, the Specialist Microbiologist will be responsible for creating the Utilities and Environmental Monitoring sampling plans, all the procedures linked to QC microbiology operations and coordinate all the microbiology activities.

During manufacturing operation, the Microbiologist specialist will be responsible for coordinating the Microbiology analysis, and provide expertise for deviation, investigation and change controls.

Essential Functions of the Job (Key responsibilities):

During the construction phase, you will mainly:

  • Author, review and maintain comprehensive systems requirements (URS) for the Microbiology equipment;
  • Author, review and maintain comprehensive work instruction;
  • Define a strategy and manage the utilities and environmental qualification:
    • Create sampling plan for environmental monitoring;
    • Create sampling plan for Utilities.
  • Actively participate in regular calls, visits, status updates with process equipment manufacturers;
  • Revise and approve Qualification protocols and reports;
  • Own (develop, document, apply, close) deviations including any corrective actions arising during verifications;
  • Prepare and deliver training to new members of the team;
  • Organize the test method qualification and/or tech transfer.

During operational phase, you will mainly:

  • Provide Microbiology expertize in case of deviation or investigation;
  • Author the environmental and utilities periodic review;
  • Author, review, approve, maintain life cycle etc.) of all required Standard Operating Procedures, Work Instructions, and other quality documents related to areas of responsibility, as well as support other areas as required;
  • Act as a mentor to more junior team members and lead by example to ensure timely analysis execution, and proactively propose problem resolution;
  • Raise, investigate and close events, deviations and non-conformances;
  • Own (develop, document, apply, close) Change Controls;
  • Contribute positively to a strong culture of business integrity and ethics;
  • Act within compliance and legal requirements as well as within company guidelines.

Qualifications (Minimal acceptable level of education, work experience, and competency):

  • Microbiology PhD or Master degree preferred or 10 years’ experience in the biotech, pharmaceutical or chemical environment;
  • Hands-on experience of equipment commissioning and qualification;
  • Demonstrated, solid hands on experience of Quality control – typically 5-10 years;
  • Knowledge in LIMS system;
  • Ability to work in a fast paced – high regulated environment;
  • French and English (Fluent);
  • Team work oriented mindset;
  • Shift work is expected.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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