Schedule: Flexible to work between 6 am and 11 pm, rotating shifts, and on weekends
Top Skills:
Desktop/System Support(MUST HAVE)
Knowledge on Lab Instruments, understanding lab processes, and adhering to policies. (MUST HAVE)
Biotech/pharma/biopharma industry experience (MUST HAVE)
Understanding and experience with Network, databases, servers, and PCs
3+ years of experience in planning and leading small and medium-sized projects preferred
3+ years of experience supporting multiple projects, with the ability to multi-task preferred
Knowledge of Incident, Problem, and Asset Management
Cyber Security Knowledge preferred
PURPOSE AND SCOPE OF POSITION
The Benchtop Support Specialist 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 are essential, as the role requires the ability to work with diverse cross-functional teams in a highly matrixed organization.
The candidate should have at least 5 years of experience in pharma/biotech, with experience in laboratory equipment, benchtop instrumentation, and quality system disciplines. The candidate needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management, and process automation in addition to prior manufacturing enterprise systems support.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices.
Thorough understanding of SOPs, cGMPs, and other compliance requirements and regulatory guidelines (FDA, EU) and ability 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.
Ability to plan and lead small and medium-sized projects and enhancements.
Self-driven with strong prioritization capabilities.
Expanding understanding of network, databases, servers, and PCs.
Familiarity with TFF systems, Nucleic Counters, Mixer, Filler, FIT, Veeva Document Management System, Infinity, ServiceNow, and emerging technology preferred.
Ability to apply lean and OpEx principles.
Professionalism and technical competency to represent the department before stakeholders, regulatory agencies, and management.
Education and Experience
Bachelor's degree in life sciences, engineering, or a computer field, or equivalent experience.
Experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices, with familiarity supporting benchtop instruments and applications within a GxP-compliant manufacturing or laboratory setting preferred.
Proven 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 benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment, covering various instruments like cellometers, plate readers, and flow cytometers across laboratory and manufacturing buildings.
Support administration of quality and laboratory applications, including software development life cycle activities and technical support.
Manage assets and utilize BMS systems for changes, incidents, problems, and asset management for benchtop equipment, lab, and quality systems.
Execute and update documentation to ensure reliability, accessibility, and security of benchtop equipment, lab, and quality systems.
Lead or support multiple projects and technical work assignments, serving as a point of contact for project stakeholders.
Perform supporting activities within the quality management system (Infinity).
Collaborate with global partners within BMS to align on solutions and implementation plans for benchtop instrumentation, including system installations, configurations, administrative support, and system validation lifecycle training.
Provide local administrative support and coordination with global partners for site quality systems and quality control supporting applications, managing tasks such as application periodic reviews, user access reviews, and account administration.
Serve as a digital plant subject matter expert (SME) to multi-functional teams, advising on application configurations, data integrity, cyber security, and regulatory defense.
Ensure alignment with BMS directives and industry guidelines for applications.
Implement technology improvements and efficiency opportunities for business and compliance advancement.
Provide on-call support as needed for commercial operations.
Working Conditions
Office and lab/cleanroom environments; PPE may be required at times.
Physical Demands
Ability to move computers and monitors from the prep room to labs, lifting up to 25 lbs.