Senior Microbiologist II - Sterilization & Validation Expert

Adecco Portugal

Monroe (NC)

On-site

USD 65,000 - 85,000

Full time

3 days ago
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Benefits offered by this job

Paid time off
401(k) with 5% company match

Job summary

Adecco Portugal is seeking a Microbiologist II to join a quality-focused team in a regulated manufacturing environment in Monroe, NC. This role blends hands-on microbiology work with opportunities to contribute to validation, investigations, and technical documentation.

You will perform microbiological testing (bioburden, endotoxin, sterility, growth promotion, cell culture, environmental monitoring) and support method validations, plus participate in sterilization validation activities in line

Qualifications

  • Bachelor's or Master's degree in Microbiology or a related scientific discipline
  • 3+ years of experience in a GMP-regulated laboratory environment
  • Experience in medical device, pharmaceutical, life sciences, or another regulated industry preferred
  • Experience or working knowledge of gamma and electron‑beam sterilization
  • Knowledge of ISO 13485 and ISO 11137
  • Strong understanding of microbiological testing, validation, laboratory documentation, and quality requirements
  • Excellent technical writing, analytical, investigative, and problem‑solving skills
  • Proficiency with Microsoft Office and laboratory‑based computer systems
  • Ability to work independently while collaborating effectively across teams

Responsibilities

  • Perform microbiological testing, including bioburden, endotoxin, sterility, growth promotion, cell culture, and environmental monitoring
  • Conduct and support microbiological method validations for medical and non‑medical devices
  • Lead and support gamma and electron‑beam sterilization validation activities in accordance with ISO 11137
  • Participate in dose audits, dose‑setting studies, dose mapping, and sterilization requalification
  • Support environmental monitoring and contamination‑control programs
  • Develop and maintain SOPs, laboratory procedures, validation protocols, and technical reports
  • Support deviations, investigations, root‑cause analysis, CAPA, and complaint‑related testing
  • Partner with Quality, Manufacturing, Engineering, and other cross‑functional teams
  • Serve as a microbiology resource and SME for new‑product initiatives
  • Review and trend microbiological data to support quality and management reporting
  • Provide training related to aseptic technique, hygiene, and microbiological practices
  • Support internal audits and external regulatory inspections

Skills

GMP experience
Microbiology testing
Technical writing
Problem solving
Independence
Cross-functional collaboration
MS Office

Education

Bachelor's degree in Microbiology
Master's degree in Microbiology

Tools

ISO 13485 knowledge
ISO 11137 knowledge
Sterilization experience

Job description

Adecco Portugal is seeking a Microbiologist II to join a quality-focused team in a regulated manufacturing environment in Monroe, NC. This role blends hands-on microbiology work with opportunities to contribute to validation, investigations, and technical documentation.

You will perform microbiological testing (bioburden, endotoxin, sterility, growth promotion, cell culture, environmental monitoring) and support method validations, plus participate in sterilization validation activities in line

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