09 - Advisor, Operations Quality ((Sterilization, Cleanroom & Lab Integrity)

General Overview

• Functional Area: Quality (QUA)

• Career Stream: Operations Quality (OPQ)

• Role: Advisor (ADV)

• Job Title: Advisor, Operations Quality (Sterilization Engineer)

• Job Code: ADV-QUA-OPQ-STER

• Job Level: Level 09

• Direct/Indirect Indicator: Indirect

Summary

Summary

The Quality Advisor (Sterilization Engineer) provides expert technical leadership, consultation, and oversight for all sterilization processes, cleanroom operations, and microbiological controls related to sterile medical devices. This role serves as the technical authority for the final quality release of sterile devices, leads the strategic design and implementation of in-house testing laboratories, and manages crucial contamination control pillars including environmental monitoring and facility pest control compliance. Additionally, the Advisor proactively identifies and executes process improvement projects to optimize lead times, reduce testing costs, and maintain strict GMP compliance.

Detailed Description

Detailed Description

Performs tasks such as, but not limited to, the following:

• Internal Lab Implementation: Lead strategy, design, equipment qualification (IQ/OQ/PQ), and setup of internal microbiological testing labs to transition outsourced testing in-house.

• Contamination & Pest Control: Oversee the Facility Pest Control program. Manage and audit third-party vendors, review trend reports, and ensure compliance with medical device regulatory requirements.

• Continuous Improvement: Spearhead quality improvement projects using Lean/Six Sigma to optimize laboratory workflows, streamline sterilization cycle times, and reduce operational costs.

• Sterile Product Release: Review run-specific batch records, dosimetric data, gas concentration charts, and biological indicators against specifications to authorize final sterile product release.

• Sterilization Validation: Design, author, and execute validation/re-validation protocols and reports for Gamma (ISO 11137) and EtO (ISO 11135) processes; manage ongoing sterilizer operations.

• Cleanroom Certification: Manage periodic qualification and recertification of controlled environments per ISO 14644. Coordinate with certification vendors and review technical balance reports.

• Environmental & Product Monitoring: Oversee the cleanroom Environmental Monitoring (EM) program. Manage product microbiology monitoring, including bioburden testing and sterility assurance.

• Laboratory & Vendor Management: Manage relationships with external contract labs and cleanroom vendors, including budgeting, test result reviews, and Purchase Order (PO) placement.

• Failure Analysis & Investigation: Lead cross-functional task forces and failure investigations (NCRs, CAPAs) for sterilization deviations, EM excursions, or cleanroom failures.

• Audits & Regulatory Compliance: Act as Subject Matter Expert (SME) during internal and external audits (FDA, Notified Body, ISO). Maintain and update serialization and cleanroom SOPs.

• Culture & Training: Actively monitor, promote, and train employees on Good Manufacturing Practices (GMP) and cleanroom behavior to strengthen facility contamination control.

Knowledge/Skills/Competencies

• Knowledge/Skills/Competencies

  • Lab Implementation & Equipment Qualification: Proven experience building or scaling up laboratory spaces, including equipment procurement, validation (IQ/OQ/PQ), method validation, and establishing standard operating procedures (SOPs).

  • Facility Contamination & Pest Control: Strong understanding of comprehensive facility contamination control vectors, including structural pest control standards and standard operating procedures required for medical device manufacturing.

  • Continuous Improvement & Lean Methodologies: Strong capability to lead continuous improvement projects using quality tools such as FMEA, DMAIC, 8D methodology, Change Control, and Risk Management (ISO 14971). Knowledge of Six Sigma or Lean Kaizen.

  • Sterile Release Authority: Proven expertise in reviewing run-specific sterilization parameters (e.g., dose mapping, gas concentration, humidity, temperature, aeration charts) against defined regulatory and internal specification limits for product release.

  • Sterilization Expertise: In-depth knowledge of sterilization modalities, specifically Gamma radiation (ISO 11137) and Ethylene Oxide (ISO 11135).

  • Cleanroom Standards: Strong working knowledge of cleanroom design, airborne particulate testing, and certification/recertification protocols according to ISO 14644 series.

  • Microbiology & Quality Control: Strong expertise in cleanroom environmental monitoring, bioburden tracking, endotoxin testing, and basic microbiological test methods.

  • Regulatory Knowledge: Deep understanding of medical device quality systems (ISO 13485, FDA 21 CFR Part 820) and GMP requirements.

  • Vendor & Financial Acumen: Experience managing third-party laboratories and testing vendors, including contract negotiation and PO placement processes.

  • Communication: Exceptional ability to communicate complex microbiological and technical data effectively to internal teams, external vendors, and regulatory auditors.

Physical Demands

• Sitting/standing, free to move around.

• Walking, including routine entry into controlled cleanroom environments (requiring gowning).

• Sustained visual concentration on monitors, screens, and laboratory data/reports.

• The job works in generally good conditions with occasional exposure (10% - 33%) to cleanroom gowning environments, noise, odors, drafts, chemicals, operating machinery, and regulated sterilization/laboratory substances.

• Occasional overnight travel is required (e.g., to external sterilization sites or contract labs).

Typical Experience

• 7 to 10 years of experience in medical device quality engineering, specifically focused on sterilization validation, internal laboratory implementation, cleanroom qualification, and microbiology.

Typical Education

• Bachelor’s Degree in Microbiology, Biology, Biomedical, Chemical Engineering, or a related scientific discipline (highly recommended for Advisor level sterilization roles to meet regulatory audit scrutiny).

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.