Senior Microbiology & Environmental Monitoring Lead

Agilent Technologies; Windsor; In loco; CAD 89.000 - 138.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus eligibility

Stock option

Benefits program

Descrizione del lavoro

Agilent Technologies in Windsor, NS, Canada seeks a seasoned Bioscience Supervisor to lead microbiology and environmental monitoring teams within a GMP/GLP environment. You will oversee investigations, validate methods, and ensure cGMP compliance while mentoring staff across QA and QC functions.

The role requires strong technical writing, regulatory knowledge, and the ability to collaborate with auditors and stakeholders to maintain high-quality manufacturing support.

Competenze

• Bachelor of Science degree in Microbiology or related discipline.
• Master of Science or PhD is considered an asset.
• 5+ years of relevant work experience in a GMP or GLP environment.
• 7+ years of Microbiology experience or relation experience in a life sciences field; or equivalent combination of education and experience.
• Previous supervision and mentorship of junior staff members is required.
• Proficiency in microbiological techniques employed in a regulatory environment: Sterility per USP, Bioburden per USP, Microbial identification, Subculturing, Media Preparation, Methodology for handling/testing materials inside a BSC.
• Experience leading environmental monitoring investigations in sterile manufacturing environments is considered an asset.
• Tracking/trending environmental monitoring data.
• Ability to lead a project within QC, including collaborating with internal and external clients, auditors and presenting data and results clearly and concisely.
• Knowledge of cGMP regulations/guidelines (Health Canada, FDA, EU Annex as well as international regulations (ICH Q & USP, EP, ISO Standards)) pertaining to the microbiology, environmental monitoring, and cleaning validation programs to support production of drug products.
• Robust technical writing skills, with experience in writing and reviewing SOP's and reports.
• Proficient communicator, both written and oral.
• Knowledge of current Good Manufacturing Practices (cGMP).
• Ability to work independently with minimal supervision or informally leading people, projects and/or programs.

Mansioni

• Oversee QC microbiology and environmental monitoring staff.
• Administer the environmental monitoring program and ensure equipment and personnel compliance.
• Ensure training of microbiology and environmental monitoring staff is up to date and compliant.
• Lead investigations to determine root causes including identifying contaminants and environmental isolates.
• Design and review validation and verification of microbiology methods and update SOPs to current guidelines (USP, ICH, FDA, Health Canada, ISPE, Ph. Eur.).
• Act as Biosafety officer for BSL2 microbiology lab and ensure PHAC guideline compliance when required.
• Provide information and presentations on the environmental monitoring program to internal stakeholders and clients.
• Review QC records for completeness, correctness and GMP compliance.
• Provide training and support for instrumental and bench techniques in the microbiology lab.
• Maintain accurate, real-time records of all laboratory activities and ensure staff maintains compliant records.

Conoscenze

Leadership

Regulatory knowledge

cGMP

Technical writing

Communication

Independent work

Project leadership

Formazione

Bachelor of Science in Microbiology

Master’s degree or PhD asset

Descrizione del lavoro

Agilent Technologies in Windsor, NS, Canada seeks a seasoned Bioscience Supervisor to lead microbiology and environmental monitoring teams within a GMP/GLP environment. You will oversee investigations, validate methods, and ensure cGMP compliance while mentoring staff across QA and QC functions.

The role requires strong technical writing, regulatory knowledge, and the ability to collaborate with auditors and stakeholders to maintain high-quality manufacturing support.