Senior Sterilization Microbiologist - Hybrid Growth

Actalent; United States; Hybrid; USD 69,000 - 83,000; Full time

Benefits offered by this job

Hybrid schedule

Benefits

Job summary

Actalent is seeking a Senior Microbiologist specializing in sterilization and quality systems. You will provide scientific leadership across regulated manufacturing environments, partnering with Manufacturing, Quality, Regulatory Affairs, and R&D to assess microbiological risks and guide product and process changes.

The role emphasizes risk-based decision making and robust scientific justification. Based in Arden Hills, MN, this contract position requires heavy collaboration across global teams,

Qualifications

• Experience performing scientific evaluations and risk assessments in microbiology and sterilization contexts.
• Strong technical writing and documentation skills for regulatory submittals.
• Proven ability to manage multiple projects and priorities in a regulated environment.
• Excellent communication to diverse, global stakeholders.
• Familiarity with quality systems and regulatory expectations for medical products.

Responsibilities

• Lead sterilization department projects with planning, execution, and documentation.
• Review design dossier and pre-market submissions for sterilization strategies and controls.
• Draft responses to regulatory questions with scientific rationale and risk-based explanations.
• Guide regulatory groups to convey sterilization requirements across development and manufacturing.
• Translate regulatory questions into corporate guidance for design dossiers and approvals.
• Review sterilization process validation and qualification documentation for consistency with standards.
• Research sterilization studies and advise on equipment development to improve safety and robustness.
• Collaborate with notified bodies to communicate strategies and provide training.

Skills

Microbiology expertise

Sterilization knowledge

Technical writing

Project management

Regulatory knowledge

Cross-functional collaboration

Education

BS/MS/PhD in microbiology or related field

Job description

Actalent is seeking a Senior Microbiologist specializing in sterilization and quality systems. You will provide scientific leadership across regulated manufacturing environments, partnering with Manufacturing, Quality, Regulatory Affairs, and R&D to assess microbiological risks and guide product and process changes.

The role emphasizes risk-based decision making and robust scientific justification. Based in Arden Hills, MN, this contract position requires heavy collaboration across global teams,