Support Engineer

Purpose And Scope Of Position

The Benchtop Support specialist position will be responsible for providing IT support in our Digital Plant organization working to support, enhance, and maintain compliance for the GxP benchtop systems and instrumentation as well as site and global applications used within the manufacturing, quality, and quality control organizations. This position requires a passion for IT, validation, and compliance. Project management and business analyst skillsets within the role as the position requires the ability to work with diverse cross-functional teams in a highly matrix organization.

REQUIRED COMPETENCIES

• Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices.
• Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
• Demonstrated leadership skills and the ability to negotiate in a complex environment.
• Excellent verbal and written communication skills.
• The ability to plan and lead small and medium size projects and enhancements.
• The candidate needs to be self-driven and capable of prioritizing.
• The candidate should have an expanding understanding of network, databases, servers, and PCs.
• Understanding of administration and usage of TFF systems, Nucleic Counters, Mixer, Filler, FIT, Veeva Document Management System, Infinity, ServiceNow and emerging technology is preferred.
• Ability to apply lean and OpEx principles.
• The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.

Education And Experience

• Bachelor’s degree in life sciences, engineering or computer field or equivalent experience.
• Experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices.
• Familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting preferred.
• Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications.

Duties And Responsibilities

• Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment.
• Support would encompass various instrument types such as cellometers, plate readers, and flow cytometers throughout the site which include laboratory and manufacturing buildings.
• Support administration of quality and laboratory applications including their software development life cycle activities and technical support.
• Execute and update documentation for the support of benchtop equipment and lab and quality systems.
• Execute and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
• Liaison with global partners within the BMS organization to align on solutions and implementation plans for benchtop instrumentation and performs system installations, configurations, administrative and support functions including system validation lifecycles and training.
• Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration.
• Provide digital plant subject matter expertise (SME), to multi-function teams, advises operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies.
• Ensure alignment with BMS directives and industry guidelines for applications.
• Execute on technology improvements and efficiency opportunities to improve business and compliance.
• Provide on-call support, as needed, for commercial operations.

Working Conditions

• Office and Lab/Clean room environments, PPE required at times.
• Physical Demands: Ability to move computers and monitors from prep room to labs, lifting up to 25lbs.