Laboratory Technologist

Job Summary

We are seeking a highly skilled Laboratory Technologist to join our team at Edwards Lifesciences. As a key member of our laboratory team, you will be responsible for providing testing services in a laboratory environment.

Key Responsibilities:

• Perform routine and non-routine testing services by using established procedures/protocols, including manufacturing investigations, D-value, B&F, FETS, glut, TLS, antimicrobial, sterility, receive, inspect, in process solutions, etc.

• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.

• Perform investigations on CAPA forms, e.g., NCRs, RICA, OOT, OOS, for tests or processes nonconformance and identify root cause and propose corrective actions for manager approval.

• Prepare data summaries, reports, and protocols using existing templates as a model, as well as review and approve basic laboratory data and may propose recommendations on template changes.

• Assist with routine manufacturing equipment validation by coordinating testing schedules and performing data analysis.

• Create and develop validation plans for laboratory equipment and methods.

• Lead laboratory investigations and propose recommendations and solutions for manager approval.

• Propose and update operating procedures and ensure that specifications are in compliance with GMP.

• May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures.

Requirements:

• Technical Diploma in Microbiology, Laboratory or Chemistry or Bachelor's Degree in Microbiology. Required.

• More than 3 years of previous experience working in a laboratory environment or in a microbiology environment. Required.

Additional Skills:

• Excellent written and verbal communication, interpersonal, and relationship building skills.

• Able to read, comprehend, write and speak English (Intermediate level).

• Excellent computer skills, including usage of MS Office; Analytical Equipment System (e.g. ChemStation Empower).

• Full knowledge of laboratory processes.

• Knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations.

• Ability to write technical documents.

• Strong knowledge with ISO microbiological sterilization documents if applicable.

• Strict attention to detail.

• Must be able to work in an inter-departmental team environment, as well as with colleagues from other departments.

• Ability to provide feedback in a professional, direct, and tactful manner.

• Ability to represent the organization to outside contacts, i.e., vendors.