Sterilization & Microbiology Specialist I

Job Description:

The Sterilization & Microbiology Specialist I supports microbiology and sterilization programs through environmental monitoring, sterilization validation and revalidation activities, contamination control assessments, data analysis, and documentation review.

This role is primarily responsible for coordinating environmental monitoring activities within controlled environments, supporting sterilization processes, evaluating contamination risks, analyzing microbiological trends, and contributing to investigations and CAPA activities. The position requires a combination of hands-on environmental monitoring activities and technical documentation review within a regulated medical device environment.

The role is not a traditional laboratory position and includes significant responsibilities related to documentation, trend analysis, environmental control programs, sterilization support activities, and quality system compliance.

WORK SCHEDULE / HOURS: Monday – Friday 8:00 a.m. – 5:00 p.m.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Coordinate sterilization validation and revalidation activities.

• Collaborate in the preparation, review, and maintenance of Sterilization and Environmental Control documentation, including:

  • Procedures

  • Protocols

  • Work Instructions

  • Forms

  • Reports

  • Environmental monitoring records

• Perform environmental monitoring activities in controlled environments, including:

  • Viable air sampling

  • Non-viable particle monitoring

  • Surface monitoring

  • Environmental sampling activities

• Monitor sterilization and environmental control results including, but not limited to:

  • PCD trends

  • Bioburden trends

  • Endotoxin trends

  • Microorganism identification results

  • Environmental monitoring trends

  • Other microbiological testing results

• Analyze environmental monitoring and sterilization data and perform trend analysis activities.

• Assess product contamination risks and support investigations and CAPAs related to sterilization and microbiology activities.

• Participate in validation and revalidation activities associated with sterilization processes.

• Lead or support biocompatibility assessments of products.

• Assess environmental controls within controlled environments, including:

  • Viable particle monitoring

  • Non-viable particle monitoring

  • Fungi monitoring

  • Bioburden monitoring

  • Alert and Action Limits review

• Evaluate cleaning and sanitation activities performed in controlled environments.

• Review technical reports and sterilization-related documentation.

• Support routine sterilization program activities.

• Support quality system audit activities.

• Support continuous improvement activities within the Quality Assurance function.

• Perform other duties within the Quality Assurance organization as assigned.

SUPERVISORY RESPONSIBILITIES

Have supervisory responsibilities: No

Leadership: N/A

Supervises: N/A

Supervision

General Direction: Receives general guidance concerning overall objectives. Work is typically performed independently while operating within department and quality system requirements.

EDUCATION AND/OR EXPERIENCE

• University Degree in:

  • Biotechnology

  • Biology

  • Microbiology

  • Biomedical Engineering

  • Biotechnology Engineering

  • Related Life Science disciplines.

• Technical degrees or diplomas in Microbiology, Laboratory Sciences, or related disciplines may also be considered.

• 1–2 years of experience in:

  • Environmental Monitoring

  • Microbiology

  • Controlled Environment Monitoring

  • Medical Device Manufacturing

  • Sterilization Support Activities

Preferred Experience

• Viable and non-viable environmental monitoring.

• Air and surface sampling.

• Aseptic techniques.

• Cleanroom operations.

• Sterilization validations and revalidations.

• Medical Device industry experience.

COMMUNICATION SKILLS

• Strong written communication skills.

• Ability to prepare technical reports and documentation.

• Ability to communicate effectively with Quality, Manufacturing, Operations, and Regulatory teams.

• English proficiency required:

  • Advanced reading and writing skills.

  • Intermediate verbal communication skills (B1-B2 preferred).

• Ability to review, understand, and generate technical documentation in English.

MATH / COMPUTER SKILLS

• Basic mathematical skills including percentages, ratios, and trend evaluation.

• Strong Microsoft Office skills, especially:

  • Excel

  • Word

  • PowerPoint

• Experience performing trend analysis using Excel.

• Experience using environmental monitoring equipment is preferred, including particle counters or related monitoring devices.

• Knowledge of statistical software packages is considered a plus.

• Ability to perform literature searches and technical investigations.

• Demonstrated problem-solving and data-analysis skills.

WORK HABITS

• Execute work assignments with limited supervision.

• Coordinate activities with multiple departments.

• Maintain accurate records and documentation.

• Maintain a clean and organized work area.

• Self-motivated and results-oriented.

• Strong attention to detail.

• Comfortable balancing both hands-on monitoring activities and documentation-intensive responsibilities.

COMPLIANCE

• Follow standard operating procedures for all assigned activities.

• Understand and comply with site Quality System requirements.

• Complete all required safety and environmental training.

• Comply with applicable regulatory, safety, environmental, and quality requirements.

MANUAL DEXTERITY

Manual dexterity sufficient to reach, handle items, perform environmental monitoring activities, and operate laboratory or monitoring equipment.

VISION REQUIREMENTS

No special vision requirements.

TRAVEL

None

ENVIRONMENTAL WORKING CONDITIONS

• Office environment.

• Controlled manufacturing environments.

• Cleanroom environments.

• Environmental monitoring areas.

PHYSICAL DEMANDS

Other Physical Working Conditions

• Lifting or carrying items.

• Moderate noise.

Physical Activity Level

Sedentary to light physical activity involving documentation review, environmental monitoring activities, and facility assessments.

COMMENTS

This position description outlines the major recurring responsibilities of the role and is not intended to be all-inclusive.

The Sterilization & Microbiology Specialist I is a relatively junior professional role that combines environmental monitoring, sterilization support, contamination control, trend analysis, investigation activities, and technical documentation responsibilities. Success in this position requires strong attention to detail, microbiology fundamentals, environmental monitoring experience, and the ability to work effectively within a highly regulated medical device environment