Sr Microbiologist-Sterili Supv

MX4 COV - Mallinckrodt Respiratory Nellc; Mexicali, Tijuana; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Medtronic is a global leader in healthcare technology seeking an experienced professional in sterility assurance, microbiology, and environmental control. You will focus on contamination control, sterilization validation, and cleanroom operations to ensure compliance and product quality.

Responsibilities include supporting EO cycle qualification, coordinating bioburden and LAL programs, and leading product transfers related to sterilization.

Formación

• Bachelor’s Degree in Biological sciences or chemical engineering.
• Experience of 8+ years in Sterilization and Microbiology.
• Knowledge of Ethylene Oxide and radiation sterilization methods.
• Experience with bioburden testing and endotoxin knowledge.
• Familiarity with ISO/IEC and GMP requirements for medical devices.

Responsabilidades

• Analyse chemical, biological or microbiological samples to support the quality program.
• Coordinate sterility assurance programs including EO cycle qualification and radiation dose audits.
• Lead product transfers and sterilization-related QA activities.
• Conduct risk assessments and CAPAs for sterilization and microbiology.
• Prepare and update documentation for sterilization and environmental control.

Conocimientos

Sterility assurance

Microbiology

Environmental control

Compliance

English proficiency

Educación

Bachelor’s Degree in Biological sciences or chemical engineering

Descripción del empleo

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

Experienced professional in sterility assurance, microbiology, and environmental control, with expertise in contamination control, sterilization validation, and cleanroom operations. Focused on compliance, product quality, and continuous improvement.

Responsibilities may include the following and other duties may be assigned.

• Anayses chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program.
• Prepares, cleans, disinfects, and/or sterilizes instruments, materials, products, and/or supplies.
• Follows protocols and regulations in order to clean, store, and/or deliver products, supplies, and/or instruments.
• Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.
• Develops, validates, and implements controlled environment methods.
• Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.
• Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
• May also be involved in establishing requirements for the transfer of methodology from R&D.
• Coordinate the sterility assurance program by leading and supporting EO cycle qualification and requalification, radiation dose audits, EO and radiation annual reviews, and other special testing activities, such as comparative resistance studies and ethylene oxide residual testing.
• Lead and support new product transfers and introductions as the sterilization and microbiology representative.
• Conduct sterilization and microbiology impact assessments for product or packaging changes.
• Coordinate and support product release activities related to sterilization.
• Coordinate the bioburden and LAL programs to ensure control, verification, and maintenance of product families.
• Develop in-house microbiology and environmental testing techniques and coordinate activities with external laboratories.
• Support environmental control activities for cleanrooms and critical facility systems.
• Maintain risk management files related to sterilization, environmental control, and microbiology.
• Generate, investigate, and follow up on nonconformances and CAPAs related to sterilization, microbiology, and environmental control.
• Maintain trend analysis for processed loads, product damage during transit or at sterilizer plants, and sterilization process failures, and prepare associated reports.
• Review and update documentation related to sterilization processes, environmental control, and microbiology.
• Support internal and external audits related to environmental control, microbiology, and sterilization.
• Support regulatory submissions related to environmental control, microbiology, and sterilization.
• Lead or participate on projects in alignment with company optimization strategies.
• Notify actions, unsafe conditions and environmental risks observations in any of the areas of the plant.
• Manage a team of technicians and/or engineers by assigning and monitoring tasks, providing ongoing coaching and feedback, and evaluating performance.

PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM

Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

DIFFERENTIATING FACTORS

• Autonomy: Supervises team members or subordinate supervisors, providing tactical and / or technical leadership. May perform ongoing operational tasks. Receives assignments in task-oriented terms and delivers results according to established procedures.
• Organizational Impact: Plans and establishes goals and objectives for a team, typically within (1) department. Decisions impact project or department schedules, customer satisfaction levels, or allocation of time or material resources. Typically does not have budget or P&L accountability, but may manage day-to-day elements of the budget (eg, overtime for staff).
• Innovation and Complexity: Makes improvements to processes, systems or products. Problems and issues faced are difficult and may require understanding of broader set of issues, including multiple job areas or specialties.
• Communication and Influence: Communicates with internal and external customers and vendors, across various levels of the organization. Shares and exchanges relevant information to reach solutions, and gaining cooperation of other parties.
• Leadership and Talent Management: May be a second level supervisor of employees in the Support career stream, such as production, distribution or technicians. May be a first level supervisor of employees in the Associate or Intermediate level in the Specialist career stream. May be a first level supervisor of employees at level IV and V in the Support career stream. Leads, directs and reviews the work of team members in order to accomplish operational plans and results. Provides primary input to hiring, firing, promotion, performance and rewards decisions for direct reports.

Required Knowledge and Experience

• Bachelor’s Degree in Biological sciences or chemical engineering
• Experience for at least 8 years in Sterilization and Microbiology area
• Experience in Principles of Ethylene Oxide, Radiation (GAMMA, Ebeam) sterilization method.
• Experience in Microbiology Principles for Product sterility, Bioburden Testing, Bacterial Endotoxin.
• Advanced English Level
• Knowledge of international standards related to sterilization, microbiology and environmental control (ISO 11135, ISO 11137, ISO 11737, ISO 10993, AAMI TIR28, ISO 14644, ISO 14698, ISO 17025, ANSI /AMMI ST72, CFR 21 part 58 and USP chapters 1116 and 1117.
• Knowledge of Medical Device Quality system (ISO 13485)
• Knowledge of Root cause analysis (Five Whys, Fishbone Diagram (Ishikawa), FMEA)
• Good Manufacturing practices and good documentation practices.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [e-mail].

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives.

Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning.

Why join us? It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.

For further information about the E-Verify program, please click here.