Microbiology Superintendent

CA03 BioVectra Inc.; Windsor; On-site; CAD 89,000 - 138,000; Full time

Job summary

Agilent Technologies Inc. in Windsor, Canada, seeks a senior supervisor to lead QC microbiology and environmental monitoring with responsibility for HR services, training, and program oversight.

You will guide investigations, validate microbiology methods, and act as Biosafety officer for the BSL2 lab, ensuring compliance with GMP and global guidelines while presenting data to stakeholders and clients.

Qualifications

• 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 related life sciences field; or equivalent education/experience.
• Previous supervision and mentorship of junior staff required.
• Proficiency in regulatory microbiology techniques per USP <71>, USP <61>, etc.
• Experience leading environmental monitoring investigations in sterile manufacturing environments is an asset.
• Tracking/trending environmental monitoring data.
• Ability to lead QC projects and collaborate with auditors/clients and present data clearly.
• Knowledge of cGMP regulations/guidelines (Health Canada, FDA, EU, ICH, USP, EP, ISO).
• Robust technical writing skills and SOP/report writing.
• Proficient communicator, both written and oral.
• Knowledge of current Good Manufacturing Practices (cGMP).
• Ability to work independently with minimal supervision.

Responsibilities

• Provide guidance and oversight to QC microbiology and environmental monitoring staff.
• Administer HR services for direct or indirect reports (pay, attendance, performance).
• Oversee environmental monitoring program for facility compliance and equipment function.
• Ensure training for microbiology and environmental monitoring staff is up-to-date.
• Lead investigation plans and root-cause analysis for quality events.
• Design/review validation/verification of microbiology methods and SOPs; maintain records.
• Act as Biosafety officer for BSL2 lab and ensure PHAC guidelines compliance.
• Present program status to internal stakeholders and clients.
• Review QC records for completeness, accuracy, and GMP compliance.
• Provide training/support for instrumental and bench techniques; maintain real-time records.

Skills

Supervision

Mentorship

Regulatory compliance

Project leadership

Technical writing

cGMP knowledge

Communication

Independent work

Education

Bachelor of Science in Microbiology or related discipline

Master of Science or PhD (asset)

Tools

SOP writing

Job description

Job Description

Providing guidance and oversight to direct or indirect reports including QC microbiology and environmental monitoring staff. Responsible for human resources services for direct or indirect reports; including pay, attendance management, and employee performance management. Administering the environmental monitoring program throughout the facility encompassing the compliance of the program, the functionality of the equipment and conduct of the personnel.

Ensuring that the training of all members of the microbiology and environmental monitoring programs are up to date and the procedures they follow are compliant. Taking a lead role in designing, outlining and executing investigation plans and the execution of any associated work to determine root causes including identifying contaminants and environmental isolates associated with quality events (non-conformances, CAPAs, etc.) Designing and reviewing the validation and verification of microbiology methods and periodically reviewing departmental and interdepartmental SOPs to ensure compliance with current guidelines including but not limited to USP, ICH, FDA, Health Canada, ISPE and Ph. Eur. Acting as the Biosafety officer for the BSL2 microbiology and lab in the facility and ensure compliance with PHAC guidelines if required. Providing information and presentations on the environmental monitoring program and microbiological lab activities to internal stakeholders and our clients. Reviewing of QC records and data for completeness, correctness and compliance with GMP. Providing training and support for instrumental and bench techniques for the microbiology lab. Maintaining accurate, real-time records of all laboratory activities and ensuring all team members are maintaining accurate, up-to-date, compliant records.

Qualifications

• 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 <71> Bioburden per USP <61> 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 (i.e. International Committee on Harmonization (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.

Additional Details

This job has a full time weekly schedule. The full-time equivalent pay range for this position is $88,536.00 - $138,338.00/yr CAD plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies Inc. is an equal opportunity employer.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Travel Required: Occasional Shift: Day Duration: No End Date Job Function: Quality/Regulatory Graduate and Student Career Site Visit our career site and learn more about Agilent Watch our video playlist to get a glimpse of life at Agilent!

As a global leader in laboratory and clinical technologies, we are passionate about bringing great science to life. Our commitment to quality and innovation supports cutting-edge life science research, patient diagnostics, and ensures the safety of water, food, and pharmaceuticals. As scientists and clinicians pursue small, everyday advances and life-changing discoveries, we provide trusted answers to their most critical questions and challenges. Leveraging more than 50 years of expertise, we create advanced instruments, software, and consumables supported by teams of highly skilled and knowledgeable people. With 18,000 employees around the world, our global reach and comprehensive solutions provide the most reliable and accurate results, as well as optimal scientific, economic, and operational outcomes. We work collaboratively with our customers on their journey to make a real difference in human lives. Our culture is founded on trust, respect, and uncompromising integrity, and we pride ourselves on being a dynamic and inclusive workplace that celebrates diversity and fosters innovation. We can’t wait for you to join us as we continue our mission to improve the world around us. Information about Agilent is available at Agilent.com.