Senior Microbiologist, Technical Specialist

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

Senior leader in Biological Quality Assurance, a division of the Quality Laboratory, leading and analyzing BQA laboratory test results within a GMP environment. Uses scientific education and/or experiences to generate results in accordance with GMP/procedural requirements and scientific principles. Works cross functionally, and with varying organizational levels, both locally and globally. Interprets data output to determine conformance with environmental, personnel and product microbial monitoring requirements/specifications and performs trend analyses. Reviews and verifies data generated by others to determine conformance with product specifications and drive continuous improvement. Understands internal business process, to make appropriate prioritization of their assigned work duties and duties of others in the lab. Has experience and command of multiple laboratory techniques to perform them with minimal error.

Key Accountabilities

• Leads and influences team members with their tasks and activities by providing on-the-floor support for both manufacturing and laboratory operations, ensuring adherence to safety rules, aseptic techniques and microbiological controls including troubleshooting and resolving microbiological issues in real-time to support uninterrupted production.
• Understands, implements, and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
• Develop and implement strategies to drive performance while maintaining best-in-class aseptic techniques in QC Micro and Operations.
• Track and trend microbiological performance data and collaborate with cross-functional teams to investigate and resolve microbiological issues and deviations to identify root causes, implementing corrective actions, and prevent recurrence through continuous improvement initiatives.
• Assists with development and delivery of microbiology related training programs including aseptic operator training.
• Leads and takes a proactive role in design, qualification/validation, and maintenance of critical aseptic technique related processes and studies.
• Provides oversight of environmental monitoring program including design and maintenance of environmental monitoring, review of routine/process environmental monitoring, water system, and compressed air for trends and supports identification of appropriate corrective/preventive actions as required.
• Assists in training, retraining, and competency assessment of employees.
• Identifies contamination risks and drives improvements related to the reduction of contamination risks on the shop floor with close cooperation with operators and management of the Manufacturing and Facilities/Maintenance departments.
• Understands FDA and ISO standards applicable to the department and consequences of nonconformance.
• Support implementation of metrics and drive the performance of the metrics.
• Participate in the SOP review and revision process.
• Performs other duties and responsibilities as assigned by the Manager, Laboratory Services.

Networking/Key relationships

Works closely with manufacturing, quality control, quality assurance, field quality, shipping, and recieving.

Minimum Knowledge & Experience required for the position:

• Bachelor's Degree (BS) from four-year college or university; or equivalent combination of education and experience; preferably in Microbiology (MSc preferred)
• Minimum of 5 years of work experience in a medical device/biopharmaceutical production/quality organization.
• Experience in microbial contamination control including in-depth knowledge of microbiological techniques, aseptic processing, and environmental monitoring.

Skills & Capabilities:

• Conducts themselves in a polite, helpful, and professional manner with all employees both inside and outside of the department.
• Understands source, composition and characteristics of products and associated microbiologi-cal, chemical and biosafety hazards.
• Interacts cooperatively with coworkers, supervisors or managers of other departments and receives direction well from superiors.
• Maintains work area, equipment, department, and all storage areas in a clean, neat, and orderly manner.
• Must be able to work within an evolving enviroment. Must be able to accept and adapt to change in work schedule on a daily basis.

Travel requirements:N/A

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com