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Provides technical leadership and oversight for sterilization processes, cleanroom operations, and microbiological controls for sterile medical devices. Leads the implementation of internal testing labs and manages contamination control and regulatory compliance.
Requires a Bachelor's degree in Microbiology, Biology, or Engineering with 7 to 10 years of experience in medical device quality engineering. Must have deep expertise in Gamma and EtO sterilization modalities and cleanroom standards.
Req ID: 137560
Remote Position: No
Region: Americas
Country: Mexico
State/Province: Nuevo Leon
City: Monterrey
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
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.
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.
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.
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).
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.
Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).
At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.
COMPANY OVERVIEW:
Celestica, Inc. (NYSE: CLS; TSX: CLS) is a technology leader dedicated to driving customer success and market advancements. With deep expertise in design, engineering, manufacturing, supply chain, and platform solutions, Celestica enables critical data center infrastructure for AI, cloud, and hybrid cloud and advances technologies in high-growth markets. With a talented team and a strategic global network, Celestica helps its customers achieve competitive advantages.
Today, Celestica delivers innovative supply chain solutions globally to customers in strategic two operating and reporting segments: Advanced Technology Solutions (ATS) and Connectivity and Cloud Solutions (CC):
ATS: This segment serves customers in complex, regulated and high-reliability markets such as Industrial & Smart Energy, Aerospace & Defense, Semiconductor Capital Equipment, and HealthTech. It is engineering led, with deep expertise in design, manufacturing and lifecycle solutions.
CCS: This segment focuses on high-performance technology solutions and services for the data center, serving hyperscalers, digital native customers and enterprises. Celestica's Platform Solutions offering provides innovative and customizable computing, storage and networking solutions enabling AI-driven growth.
Built on a legacy of trust and performance, Celestica has earned its reputation by delivering results in complex and fast-changing markets. Celestica exceeds customer expectations by identifying trends and staying ahead of the curve. Backed by comprehensive capabilities and a global network across North America, Europe and Asia, Celestica helps customers gain competitive advantage with the quality, flexibility and resiliency they need to respond quickly to shifts in demand. Guided by a bold vision to accelerate market advancements, Celestica delivers innovative solutions and technologies that turn complexity into opportunity. Anchored in teamwork and commitment, Celestica strives to be the most trusted partner to its customers and colleagues worldwide.
Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.
We imagine, design, and build the solutions that move the world forward.
Celestica is a global technology and innovation partner driven by curiosity and conviction. As a pioneer in technology, we enable critical data center infrastructure for the world's leading hyperscalers, powering AI, cloud, and hybrid cloud at an unprecedented scale. Our work advances high-growth markets from aerospace to healthcare to enterprise, delivering technology that drives real-world innovation. With unwavering dedication to both our customers and colleagues, we empower transformative growth with every solution we deliver. Together, we make great things happen—and move the world forward.
Offices: 5140 Yonge St, 1900, Toronto, Ontario M2N 6L7, CA · 5325 Hellyer Ave, San Jose, CA 95138, US · 3333 Unity Dr, Suite A, Mississauga, Ontario L5L 4A4, CA · 5201 Great America Pkwy, Santa Clara, California 95054, US · Calle Octava, Parque Industrial Monterrey, #102, Apodaca, Nuevo Leon 66600, MX
