Sterilization Manager

Avighna Quality Consulting Services; United States; Remote; USD 200,000 - 260,000; Full time

Benefits offered by this job

Travel to client sites

Remote work

Support from AVIGHNA QA Consulting

Job summary

AVIGHNA QA Consulting Pvt Ltd seeks a Sterilization Manager to lead EO sterilization and contamination control for a high-precision medical device contract manufacturer. You will own EO processes, validate and requalify cycles, and ensure compliance to ISO 11135, 10993-7, and ISO 14644 across the site.

You will head the sterility assurance program, oversee environmental and personnel monitoring, guide QA leadership, and drive audits with FDA/Notified Bodies while mentoring the local team.

Qualifications

• Must have overall 20+ years in medical device sterilization, microbiology and quality.
• Hands-on EO sterilization operation and validation to ISO 11135.
• Proven record resolving bioburden issues and running bioburden programs to ISO 11737.
• Direct oversight of aseptic-area EM (VPC/NVPC) and personnel monitoring.
• Front-line audit/inspection experience with US FDA or Notified Bodies.

Responsibilities

• EO sterilization: operate, monitor, troubleshoot cycles and review records.
• Bioburden and product microbiology: investigate excursions and oversee testing.
• Aseptic operations and environmental monitoring: manage EM program and personnel monitoring.
• Aseptic personnel qualification: train and qualify aseptic-entry personnel.
• Quality system, compliance and leadership: lead audits, CAPAs and changes; align with standards.

Skills

Sterilization leadership

Bioburden analysis

Environmental monitoring

Regulatory audits

ISO 13485 knowledge

English communication

Education

Microbiology degree

Master's or PhD preferred

Job description

AVIGHNA QA Consulting Pvt Ltd

Every obstacle removed. Every box checked.

JOB DESCRIPTION

Sterilization Manager

Sterility Assurance & Contamination Control

Engagement

Contract, 12+ months. Urgent need, immediate start

Location

APAC region. Remote, with travel to client site as needed

Reports to

Site Quality Head / Regional Quality & Regulatory Lead

Experience

20+ years in medical device sterilization, microbiology and quality

Compensation

Competitive contract rate, based on experience

ABOUT THE ENGAGEMENT

Our client manufactures sterile medical device components for global markets. They need a hands-on leader to take charge of ethylene oxide (EO) sterilization and aseptic operations, resolve current bioburden and validation issues, and leave behind an inspection-ready contamination control program.

PURPOSE OF THE ROLE

You will be the site's subject-matter expert for sterilization, microbiology and contamination control. You will own the EO process, close sterility failures, and run environmental and personnel monitoring for the aseptic area. All work must stand up to US FDA, EU MDR, ISO and Notified Body scrutiny.

KEY RESPONSIBILITIES

EO sterilization: operation, control and troubleshooting

• Operate, monitor and control EO sterilization equipment and cycles; review cycle records and parametric release data.
• Lead investigations into Biological Indicator (BI) positives during half-cycle and other validation runs, including corrective action and re-validation strategy.
• Own initial validation, requalification and annual review of EO processes to ISO 11135; control EO residuals to ISO 10993-7.

Bioburden and product microbiology

• Investigate and resolve bioburden excursions and adverse trends.
• Oversee bioburden, bacterial endotoxin (BET), sterility and product-cleanliness testing to ISO 11737-1/-2.
• Set and justify alert and action limits; link bioburden data to cycle-lethality decisions.

Aseptic operations and environmental monitoring

• Oversee aseptic operations and the environmental monitoring (EM) program for viable (VPC) and non-viable particle counts (NVPC).
• Review trends in viable and non-viable data and in personnel microbiological monitoring; raise excursions, drive investigations and recommend action.
• Maintain cleanroom classification and requalification to ISO 14644 and ISO 14698.

Aseptic personnel qualification

• Train everyone entering the aseptic area on gowning, aseptic behaviour and contamination control.
• Qualify, requalify and disqualify personnel for aseptic area entry based on gowning qualification and monitoring results.

Quality system, compliance and leadership

• Act as sterility assurance SME in internal, Notified Body, customer and regulatory audits, including front-room and back-room support.
• Lead remediation of audit and inspection findings in sterilization, microbiology and contamination control.
• Drive CAPAs, deviations and change controls in this area, with meaningful effectiveness checks.
• Assess changes to international standards and build them into site procedures.
• Prepare metrics and trend reports for senior management; set clear escalation routes for quality and compliance risks.
• Partner with R&D, Manufacturing, Regulatory Affairs, Quality and Operations on new products, process and packaging changes, and remediation.
• Coach and develop the local microbiology and sterilization team.

MUST-HAVE

• Degree in Microbiology, Biotechnology, Pharmacy, Life Sciences or a related field (Master's or PhD preferred).
• 20+ years in the medical device (or closely related sterile products) industry, covering sterilization, microbiology and quality.
• Hands-on EO sterilization: cycle operation and validation/requalification to ISO 11135.
• Proven record resolving bioburden issues and running bioburden programs to ISO 11737.
• Direct oversight of aseptic-area EM (VPC, NVPC, personnel and utility monitoring), trend analysis and excursion investigation.
• Experience qualifying and disqualifying aseptic-area personnel.
• Front-line audit and inspection experience with US FDA and/or Notified Bodies.
• Strong working knowledge of ISO 13485, 21 CFR 820 (QMSR), EU MDR and global quality system requirements.
• Clear written and spoken English; able to influence senior stakeholders and cross-functional teams.

NICE-TO-HAVE

• Radiation sterilization (gamma, e-beam, X-ray) to ISO 11137, or other modalities (VHP, steam, dry heat).
• Leading global or multi-site teams and harmonizing processes across sites.
• Managing contract sterilizers and test labs in APAC.
• Familiarity with the EU GMP Annex 1 contamination control strategy (CCS).
• Supplier qualification and integration of acquired sites.
• Membership in AAMI, PDA, ISPE or standards working groups; Six Sigma or lead auditor certification.
• Additional regional language(s).

STANDARDS AND REGULATIONS

ISO 11135 • ISO 11137 • ISO 11737-1/-2 • ISO 10993-7 • ISO 14644 • ISO 14698 • ISO 13485 • ISO 14971 • 21 CFR 820 (QMSR) • EU MDR 2017/745 • AAMI TIRs • EU GMP Annex 1 (where applicable)

WHAT WE OFFER

• A high-impact contract leading sterility assurance for an established medical device contract manufacturer.
• Competitive contract rate, based on experience.
• Support from AVIGHNA QA Consulting throughout the engagement.