Sterility Assurance & Microbiology Lead

Ambu A/S; Ciudad Juárez; Presencial; MXN 1,281,000 - 1,740,000; Jornada completa

Descripción de la vacante

A leading medical devices company is seeking a Sterility Assurance & Microbiology Lead to manage microbiology and sterilization activities at their manufacturing facility in Ciudad Juárez, Mexico. The ideal candidate will have a Bachelor's degree, over 5 years of Quality experience, and knowledge in cGMP and ISO standards. This role will involve conducting sterility assessments, bioburden testing, and ensuring compliance with health standards. The company offers a dynamic work environment focusing on safety and quality.

Formación

• 5+ years of experience working in Quality.
• Experience in the medical device industry.
• Experience working in manufacturing is preferred.
• Able to read, write, and understand English.

Responsabilidades

• Contribute to technical feasibility analysis for sterility assurance.
• Design and perform Sterility Assurance Assessments.
• Conduct bioburden testing and analyze results.
• Prepare materials for cleanroom monitoring.

Conocimientos

Technical feasibility analysis

Microbiology inputs

Analytical process tools

Good Documentation Practices (GDP)

Knowledge of cGMP and ISO standards

Educación

Bachelor's degree in a related field

Descripción del empleo

A global job position with an impact:

We are growing and expanding our Manufacturing Site in Mexico! In the job as Sterility Assurance & Microbiology Lead is responsible for the administration and coordination of microbiology and sterilization activities and testing.

Responsibilities and Essential Functions:

• Contribute to technical feasibility analysis of complex research and design concepts including microbiology inputs for the sterility assurance and related controls for the products.
• Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality, cost optimization and cycle-time.
• Design and perform Sterility Assurance Assessments and Sterilization qualification & validation studies in support of medical devices.
• Perform standard sterilization engineering assignments for application, validity and conformance to specifications.
• Utilize analytical process tools to solve complex process problems (e.g., FMEA, Risk Analysis, Process Modeling, Design of Experiments). Lead small project teams as needed to accomplish project objectives.
• Study and recommend techniques to improve existing products/processes and process controls.
• Analysis and evaluation of sterilization studies data and assist in the preparation of documentation using Good Documentation Practices (GDP).
• Employ appropriate techniques and methods to successfully conduct specific assignments within negotiated deadlines after receiving general instruction.
• Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks.
• Prepare, control and dispose of required materials to monitor the environmental condition of cleanroom to be following applicable standards.
• Define alert and action levels on cleanroom based on historical data.
• Knowledge around microbiological aspects of biological indicators, and related microbiological concepts.
• Responsible for all activities related to cleanroom monitoring and recertification.
• Responsible for coordinating bioburden testing and analyzing results.
• Responsible for the review of certification of sterilization and release of product.
• All other duties as assigned.

Authority:

• Sterilization release of Ambu A/S products.
• Reject sterilization release of product/lot and escalat any problems to NCR/CAPA.
• Reject the sterilization release of product/lot, if disagree with the disposition of an NCR or CAPA.
• Make NCR's, CAPA's and SCAR's following our existing procedures.
• Stop manufacturing if production represents a quality risk.
• Put product on hold.

Qualifications / Education:

• Bachelor's degree in a related field.
• 5+ years of experience working in Quality.
• Experience on medical device industry.
• Experience working in manufacturing preferred.
• Knowledge in the areas of GDP, cGMP, ISO 13485, and applicable microbiology and sterility assurance standards is highly preferred (ISO 14644, ISO 11135, EN 17141).
• Shall be able to read, write and understand English.

Work Environment:

This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.

How to Apply:

If you are interested in the position, then please apply as soon as possible through our recruitment system. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate.

This job ad will be online until Novembre 30,2025, but once we have found the right candidate, this ad will no longer be online. For more information about the position, please feel free to contact at [e-mail].