Microbiology Method Validation Specialist

1. JOB OBJECTIVES

Under the supervision of the Head of Microbiology, the incumbent is responsible for drafting protocols, reports and methods related to the validation, transfer and development of microbiology analytical methods or any other project requiring a solution for microbiology methods.

2. PRIMARY FUNCTIONS

• Drafting of protocols, reports and methods for microbiological validation and transfer according to USP

and Ph.Eur for various products under development.

• Execution of the various protocols required in the validation of Sterility, Endotoxin, Microlimit and Filter

methods.

• Preparation and planning of documentation, materials and consumables required for the completion of

projects and the implementation of procedures.

• Participation in various meetings related to new product development.

• Contribute to OOS investigations related to current analyses.

• Act as an expert within the scope of his/her duties.

• Perform any other related tasks deemed pertinent to the position.

• Adherence to established schedule.

3. EXPERIENCE REQUIREMENT AND APTITUDES

• Bachelor’s degree in Microbiology, Master’s degree in Microbiology an asset.

• 3 to 5 years of experience in applied microbiology in the pharmaceutical field, performing and validating

analytical methods in endotoxin, sterility and microlimit microbiology.

• Sound knowledge and understanding of GMP.

• Knowledge of regulations related to method validation and execution.

• Bilinguisme (French and English) and excellent written and oral communication skills.

• Knowledge of computer tools.

• Autonomy, initiative, resourcefulness and leadership skills.

• Sense of organization and prioritization.

• Ability to analyze, synthesize and apply sound judgment.

• Interpersonal communication and problem-solving skills.

• Team spirit and interpersonal skills.

• Ability to manage priorities and work under pressure with tight deadlines/frequent changes of priority.