Job Description

This is a full-time position to work Monday to Friday from 8am to 5pm in our Heredia site, located in Zona Franca Metropolitana.

Main Purpose: Our Microbiology Coordinators directs implementation and management of cleanroom and sterilization validation, microbiological analysis, and environmental control at the direction of the Quality Director for site activities.

Responsible for continuous review of FDA regulations, ISO standards, quality assurance philosophy, practices, and procedures to recommend compliant procedures and cost-effective solutions.

Establishes and ensures maintenance of training programs for quality control personnel in regard to sterilization and environmental control.

In addition, the position requires periodic support of other Viant Medical facilities, providing technical guidance for evaluating and assessing compliance with customer requirements.

Key Responsibilities

• Prepare and update quality documents and any applicable documentation required to sustain the microbiology department function.
• Execute reviewing / approval of any documentation created / updated by the Microbiology Technician required to sustain the microbiology department.
• Checks, provides support and executes initiation / investigation for NCs, Complaints, Calibration and Environmental Monitoring.
• Assure that all testing equipment is in compliance to perform the microbiology analysis and testing activities.
• Participates in all the readiness activities required to receive Internal / External / Customer Quality System Audits.
• Get involved in various stages of equipment and processes validations: run and / or review protocols and reports for IQ, OQ, PQ and TMV; as well as any other document relating to validation.
• Completes investigation of out of specification and completion of appropriate documentation
• Performs or coordinate microbiology testing as offered by the Microbiology Lab, including LAL, Bioburden, Environmental monitoring.
• Responsible for the preparation of quality metrics required for Management Review.
• Performs other duties, tasks, or projects at the direction of the immediate supervisor or other teammates.
• Establishes and ensures compliance with good housekeeping practices, employee hygiene, and equipment sanitation.
• Become supervisor of Microbiology Technician and be responsible for the tasks assignation / coordination of this personnel in charge.
• Train Microbiology Technician personnel in understanding of procedures, specifications, environmental controls, etc.
• Coordinate and collect environmental controlled data for site clean rooms.
• Responsible for the preparation of quality metrics required for Management Review, Operations Review, Quality Metrics or any other meetings. Also, participate in the presentation of these metrics.
• Participate, lead and propose new VIP projects providing guidance for other areas as Engineering, Facilities, and Production and into the microbiology area implementing VIP projects.

Requirements

• Basic knowledge of FDA Quality System Regulation, Medical Device Directive, ISO 13485, process validation requirements.
• Basic Knowledge of GMPs, ISO, USP and FDA regulations as they relate to laboratory operations and investigations and sterilization is a plus.
• Basic knowledge and application of statistical techniques (basic descriptive statistics).
• Basic knowledge in root cause analysis tools.
• Knowledge of Minitab statistical software.

Work Experience:

• From 0 to 3 years of work experience within the medical device or pharmaceutical in the monitoring and control of clean room environments field.

Education / Certifications:

• Minimum education required to perform duties: B.S. in Biotechnology, Biology, Microbiology, Chemistry, or equivalent field or Technical Degree, Diploma in Biotechnology, Biology, Microbiology, Chemistry plus equivalent experience of at least 5 years or proven work experience in the same field.
• Basic to Intermediate English proficiency, A2–B2.

Skills / Competencies:

Good interpersonal skills and the ability to communicate orally and in writing.

Proactive

Customer oriented

Team player

Diligent

Retentive

Good learner

Ability to work independently and follow both verbal and written instructions

Physical Requirements of the Position:

Usual office environment with frequent sitting, walking, and standing, and occasional climbing, stooping, kneeling, and crouching.

Frequent use of eye, hand, and finger coordination enabling use of office machinery

Occasional lifting up to 30 pounds.

Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.