Senior Microbiologist, GMP Sterile Manufacturing Lead

API (Applied Pharmaceutical Innovation); Edmonton; On-site; CAD 110,000 - 160,000; Full time

Benefits offered by this job

Health Coverage

RRSP Matching

Professional Development

Generous PTO

Green Transit Allowance

Work From Home 20 days

Job summary

Applied Pharmaceutical Innovation (API) in Edmonton seeks a Senior Microbiologist to lead and support microbiology operations for a GMP‑compliant sterile pharmaceutical manufacturing facility. You will oversee lab systems qualification, environmental monitoring programs, contamination control strategies, and microbiological testing to ensure Health Canada, FDA, EU GMP, and Annex 1 compliance.

The role requires full‑time on‑site presence, close collaboration with production, quality, and external

Qualifications

• Bachelor's degree in Microbiology or related field.
• 3+ years in microbiology in GMP aseptic manufacturing.
• Experience with microbial and endotoxin testing.
• Strong knowledge of GMP, FDA, Health Canada and EU regulations.

Responsibilities

• 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.

Skills

Regulatory knowledge

Mentorship

Documentation

Communication

Education

Bachelor's degree in Microbiology

Tools

Isolator

Vitek 2

Biosafety Cabinets

Autoclave

Incubators

Particle counters

Air samplers

Compressed gas samplers

Job description

Applied Pharmaceutical Innovation (API) in Edmonton seeks a Senior Microbiologist to lead and support microbiology operations for a GMP‑compliant sterile pharmaceutical manufacturing facility. You will oversee lab systems qualification, environmental monitoring programs, contamination control strategies, and microbiological testing to ensure Health Canada, FDA, EU GMP, and Annex 1 compliance.

The role requires full‑time on‑site presence, close collaboration with production, quality, and external