Laboratory Technician Iv (Mérida)

Summary

The position of Micro Laboratory Technician IV is responsible for general Microbiology laboratory support and routine testing in accordance with established laboratory test methods and procedures to support the accurate manufacturing and delivery of products to our customers. The Laboratory Technician IV will be able to provide training and guidance to less experienced technicians and guide them through special projects.

Essential Duties and Responsibilities

• Responsible for performing routine Environmental Monitoring sampling, including viable/non-viable air and surface sampling, related to the Controlled manufacturing Environment.
• Preparation of material.
• Routine sample analysis using applicable test methods.
• Capture of samples in electronic systems and laboratory manuals that could include record books and maintenance of control numbers.
• Execution and monitoring of routine and special tests through MOCCME (Microbiology) using laboratory instruments.
• Know how to recognize problems during analysis and testing.
• Initiate, participate and/or close investigations for non-conforming laboratory tests and/or environmental excursions.
• Execution of verifications related to calibration of laboratory instruments.
• Ensures equipment and materials are used within current calibration/expiration dates.
• Make and record laboratory observations and calculations.
• Collect and prepare data for evaluation and/or trend analysis.
• Timely purchases of materials and instruments for laboratory tests.
• Archive documentation of tests that have been completed.
• Execute other duties that are assigned by the laboratory management and/or immediate Supervisor.
• Assist and train/certify less experienced technicians.
• Preparation and presentation of laboratory metrics.
• Keep work area clean and in compliance with the 5's program.
• Support to internal laboratory, environmental and safety activities.
• Actively participate during the execution of activities as part of validation or revalidation of the different equipment and systems controlled by the laboratory.
• Participate in revision for the Good Manufacturing Practices.
• Follow established EHS policies and procedures at the plant, as well as participate in Safety and Environmental programs. Report hazards and incidents and collaborate to find solutions or implement improvements.
• Comply with Good Documentation Practices.
• Perform Bacterial Identification testing and reports.

Extended Duties (if applicable)

• N/A

Education Requirements

• HS diploma or bachelor’s degree in biology, microbiology, or scientific field.

Further Education (if applicable)

• N/A

Experience

• Medical Device Industry experience, preferred.
• Microbiological Quality and Sterility Assurance, preferred.
• Requires (4-6) years related experience.

Interpersonal Skills/Characteristics (if applicable)

• Ability to effectively present information and respond to questions from groups of managers, clients, customers, etc.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Communication (written and verbal)
• Negotiation / influencing
• Sterility Assurance knowledge.
• Analytical & Creative thinking.
• Project Management skills to support multiple projects simultaneously.
• Problem-solving & priority setting.
• Training in Good Manufacturing Practices (GMP) and ISO requirements.
• Knowledge and execution of Good Laboratory Practices (GLP).
• Knowledge and execution of Good Documentation Practices (GDP).
• Ability to communicate orally and in writing.
• Good interpersonal and organizational skills.
• Self-motivated.
• Abilities to use PCs and basic computer programs (Microsoft Office).

Other Requirements (if applicable)

• N/A

Minimum Language Required

• German: Business fluent for German speaking sites
• English: Business fluent
• Italian: Business fluent for Italian speaking sites
• French: Business fluent for French speaking sites
• Spanish: Business fluent for Spanish speaking sites

Special Working Conditions / Security Aspects (if applicable)

Climate controlled office environment during normal business hour. Regular business hours.