Microbiology Validation Technician

Recruiter
Marketplace
Location
Watford
Salary
Competitive
Posted
27 Aug 2019
Closes
24 Sep 2019
Contract Type
Permanent
Hours
Full Time

International Pharmaceutical Manufacturer based in Hertfordshire requires Microbiology Validation Technician to assist with the evaluation, development and validation of novel techniques. This will involve the design and execution of validation studies and the preparation of validation protocols and reports.

Main Duties:

  • Devise, plan, execute, assess results, and report microbiological validation tests and equipment qualifications using Standard Operating Procedures and Validation Protocols.
  • To clean, calibrate and maintain equipment; prepare and maintain reagents, standards, microbial cultures, or control samples; perform stock checks; and perform general laboratory housekeeping duties.
  • To promptly report and investigate any out-of-limits, invalid tests or deviations from expected results or documented procedures.
  • Ensure adherence to compliance requirements, especially GMP, at all times.
  • To operate a variety of analytical instrumentation and sophisticated computer software packages intended for data analysis, collation and other related applications. To assist in data collection, analysis, and statistical processing.
  • To identify, initiate and direct documentation preparation and revision, review.
  • To observe laboratory health and safety instructions and contribute to the development and improvement of safer working practices. To perform and review general risk assessments.
  • To take day-to-day responsibility for the execution of microbiological experiments.
  • To take responsibility for and deliver training and assessment in support of new methods or equipment, e.g. transfer to the microbiology laboratory.
  • To attend site meetings and to represent the department as required.
  • To assist in preparing monthly reports and review of results and data trends.
  • To assist with the preparation of regulatory or licence documentation.
  • To maintain contact with external suppliers and technical specialists.
  • To participate in the receipt of audits from internal and external sources.
  • To assist with maintaining the records and data integrity for own data and for systems across the Microbiology department.
  • To perform any other aspects of laboratory testing and support for Microbiology as required.

Essential experience:-

  • Must have a Bioscience or Microbiology Degree (Essential)
  • Devise, plan, execute, assess results, and report microbiological validation tests and equipment qualifications using Standard Operating Procedures and Validation Protocols.
  • Method Development Experiment / Rapid Biological Methods experience
  • To clean, calibrate and maintain equipment; prepare and maintain reagents, standards, microbial cultures, or control samples; perform stock checks; and perform general laboratory housekeeping duties.
  • To promptly report and investigate any out-of-limits, invalid tests or deviations from expected results or documented procedures.
  • Ensure adherence to compliance requirements, especially GMP, at all times.
  • To operate a variety of analytical instrumentation and sophisticated computer software packages intended for data analysis, collation and other related applications. To assist in data collection, analysis, and statistical processing.
  • To identify, initiate and direct documentation preparation and revision, review.

A good theoretical understanding of method and equipment validation will also be considered.