Site Microbiologist

Takeda • Brooklyn Park, MN

2d

About The Position

As the Site Microbiologist, you will oversee activities within the facility to ensure the microbial quality, safety, and compliance of pharmaceutical products, raw materials, utilities, cleanrooms, and manufacturing processes. You will support routine operations, investigations, environmental monitoring (EM), contamination control strategies (CCS), method development, and regulatory compliance within GMP environments. You will hold a PhD in Microbiology or a related field and have experience in virology within a regulated environment. You will report into the Site Quality Head.

Requirements

• PhD in Microbiology, Virology, Biotechnology, or a closely related life sciences discipline
• 3–7 years of experience in pharmaceutical microbiology
• 3+ years of experience with GMP, aseptic processing, and regulatory microbiology requirements
• 3+ years of experience in environmental monitoring, sterility assurance, and contamination control

Responsibilities

• Perform and/or oversee microbiological testing including bioburden, endotoxin, sterility testing, microbial identification, growth promotion, and water system monitoring
• Ensure all testing complies with GMP, SOPs, and pharmacopeial standards
• Oversee troubleshooting and qualification of microbiology laboratory equipment and advanced microbial detection systems
• Manage the Environmental Monitoring (EM) program, including trend analysis, alert/action limit review, and CAPA activity
• Support and continuously improve the site's Contamination Control Strategy (CCS)
• Supervise personnel monitoring, viable and non-viable particulate monitoring, and surface sampling in compliance with EU GMP Annex 1 and FDA guidance
• Lead microbiology-related investigations, including EM excursions, OOS/OOT results, sterility failures, and water-system deviations
• Provide microbiological expertise in risk assessments, CAPAs, change controls, and root cause analyses
• Collaborate with QA, Engineering, and Operations to proactively identify and mitigate contamination risks.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees