The Senior Microbiologist is responsible for leading and supporting microbiology operations for a GMP-compliant sterile pharmaceutical manufacturing facility. This role oversees the implementation and qualification of microbiology laboratory systems, environmental monitoring programs, contamination control strategies, and microbiological testing to ensure compliance with Health Canada, FDA, EU GMP, and Annex 1 requirements.

** Please note this position requires full-time on-site presence.

Key Responsibilities, include but are not limited to:

Implementation of a Microbiology system for Operations:

• Knowledge of regulatory requirements (Health Canada, FDA and EU) for microbiology testing related to the manufacturing of sterile pharmaceutical products.
• Assist in qualification of a new CMPC Microbiology Lab to meet GMP requirements.
• Leading Qualification activities and writing URS, VRA, VP and other qualification documents for microbiology-specific instruments such as autoclaves, incubators, Vitek and other laboratory equipment common in the GMP testing micro lab.
• Write procedures for environmental monitoring systems and microbiology lab operations for new sterile manufacturing facility (CMPC)
• Qualify equipment and perform risk assessments for environmental monitoring.
• Assist Media-fill strategy and cleaning procedures together with production.
• Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality.
• Providing daily in-lab mentorship to the microbiologists, fostering strong techniques, aseptic practices, and microbiological best practices.
• Reviewing microbial data, protocols, reports, and testing documentation.
• Extensive Knowledge of EMPQ and EU Annex 1 guidelines.
• Ability to perform comprehensive gap analysis and implement actions to meet requirements.
• Set up a contamination control strategy for the site.
• Act as Alternate Biosafety Officer and write procedures to support HPTA and DEL License.

Operations:

• Perform raw materials, in process, water, clean steam samples and sterility testing.
• Perform routine environmental monitoring for the cleanrooms.
• Perform routine record review and data analysis to identify trends.
• Update management on trends and implement corrective action plans when necessary.
• Writing microbiological Standard Operating Procedures, method/equipment qualification protocols and method transfers.
• Experienced with handling wide range of microbiological equipment like Isolator, Vitek 2 compact, Biosafety Cabinets, Autoclave, Incubators, particle counters, air samplers and compressed gas samplers.
• Proficient in interpreting microbiological test results, including colony counts, growth characteristics.
• Extensive experience in conducting microbial endotoxin OOS investigations or Media Fill deviations and the implementation of corrective actions and preventive actions (CAPAs).
• Compile and review Change controls related to the microbiological department
• Troubleshoot technical issues and difficulties with microbiological testing methods, ensuring accuracy and reliability.
• Interact with clients to maintain positive relationships and ensure their microbiological testing needs are met.
• Perform and oversee regular system qualification and calibration for microbiological testing equipment to maintain accuracy and compliance with regulatory standards.

HSE:

• Responsible for all HSE regulations in the department.
• Responsible for all Biosafety regulations in the department.

Qualifications - (Education, Certification, Degree, Skills, Knowledge, etc.)

Education

• Minimum Bachelor's degree in Microbiology or related areas.

Experience:

• 3+ years of experience as Microbiologist/Senior Microbiologist within a biotechnology/pharmaceutical aseptic manufacturing environment facility is required.
• Demonstrated experience in microbial and endotoxin testing of in-process & finished product, aseptic process simulations, environmental monitoring and testing of utilities (water, steam, etc.).
• Thorough knowledge of GMP, FDA, Health Canada and EU regulations (especially sterile manufacturing) and guidance's, combined with the ability to adopt best practices by responding quickly to a changing regulatory environment is preferred.
• Knowledge on USP, USP, USP , USP is preferred.
• Experience as Biosafety /Alternative Biosafety officer is an asset.

Personal Competencies

• Strong oral and written communication skills, with the ability to handle confidential information and frequent internal and external interactions.
• Excellent attention to detail and critical thinking.
• Ability to manage time effectively and prioritize tasks in a fast-paced environment.
• Ability to meet deadlines and troubleshoot problems efficiently.
• Ability to work independently and as part of a team to achieve organizational objectives.
• Technically adaptable, flexible, and forward-thinking.
• Committed to continuous learning, reviewing scientific literature, and staying current with new technical and scientific information.

Working Conditions:

• Required travel between Edmonton API sites.
• This position requires you to be on site.
• Occasional moderate physical activity, including standing, walking, lifting, and keyboarding.

Additional Required Documents to Support Application

• Applications submitted without a resume AND cover letter will not be reviewed.

Perks and Benefits at API

Comprehensive Health Coverage: At API, we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered, ensuring that you and your dependents receive the necessary healthcare support.

Retirement Savings: API offers a RRSP Matching Program. Employees may be eligible to participate, with API matching of contributions up to 1-3% of base salary, in accordance with program terms.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities, including training programs, workshops, conferences, and certifications. We encourage employees to enhance their skills, broaden their knowledge, and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API, we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork, open communication, and a supportive atmosphere where everyone's contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program, which promotes the use of environmentally friendly modes of transportation. By participating in the program, you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking, biking, carpooling, and public transportation.

Work From Home: Eligible employees are entitled to 20 Work from Home days, this is subject to job function, company needs, and manager approval.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants' interest and will only contact those selected for interviews.

If you have any questions about the application process or require accommodations during the hiring process, please contact [redacted].

This position will remain open until filled.