Job Title:  Support Specialist

Experience: 3 years

Top 3-5 Skills:

• Technical Support & Troubleshooting
• Both roles require hands-on support for lab/benchtop instruments, PCs, and applications, with a focus on resolving technical issues quickly.
• System & Network Administration
• Managing servers, workstations, networks, security patches, connectivity, and hardware/software environments.
• GxP / GMP Compliance & Data Integrity Knowledge
• Strong understanding of regulatory requirements (FDA/EU), data integrity, documentation practices, system validation, and work in regulated pharma/biotech environments.
• Project Management & Cross-Functional Collaboration
• Leading or supporting projects and coordinating with lab staff, quality teams, IT, manufacturing, and global partners.
• Data Management & Cybersecurity Awareness
• Backups, storage, recovery, system security, access control, and ensuring reliable, secure, compliant data handling. 

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.

The candidate should have 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.

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.
• Provide ownership of assets and utilize client systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems.
• Execute and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure.
• Execute and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
• Lead or provide supporting activities within the quality management system (Infinity)
• Liaison with global partners within the client 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 client 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.