Overview
The Lab IT Systems Specialist will fill a critical role our Philadelphia manufacturing facility and office. The ideal candidate will possess excellent technology troubleshooting, communication and customer service skills. The position will spend majority of the time helping with IT needs in the laboratory and manufacturing cleanroom areas and the personnel supporting these functions while maintaining operations to minimize equipment downtime, staying GxP compliant maintaining system data integrity.
Specific Responsibilities
- Act as IT administrator on various IT systems in laboratory areas, including areas operating to the standards of Good Manufacturing Practices (GMP), and assist with tasks such as setting up systems, users, roles, access levels, user onboarding training, etc.
- Provide tier-2 support of application incidents reported through the help desk in the laboratory systems
- Work with application vendors and provide assistance to resolve application issues, maintenance items, and enhancement requests.
- Perform daily monitoring of laboratory and R&D applications in production
- Lead small to medium complexity IT software installations, upgrade initiatives or enhancements to workflows including the design, build, and test phases.
- Implement changes using documented procedures that are compliant with each department's policies and procedures.
- Take ownership of operational issues and act as a liaison between customer and other support staff to facilitate resolution.
- Ensure data is backed up appropriately in the laboratory
- Work with business users in developing test cases for new or enhanced department applications. Builds relationships with the business users and presents ideas clearly and concisely.
- Participate in the installation and support of hardware and
- Become a member of the after-hours and on-call support staff, maintaining minimal operational downtime for the 24x7 manufacturing site.
- Anticipates problems, provides solutions to complex problems with the necessary priorities, and presents the solution to the business partners.
- Perform or participate in analysis of systems/applications/databases and in the coordination of implementation and maintenance plans, including troubleshooting issues.
- Assist in developing department education materials and training of core users of the current laboratory system.
- Serve as primary IT contact for the laboratory, clean room systems, and for End Users ensuring both vendor and internal activities are on track through well-defined action plans and communication.
- Support Laptops, desktops, hardware, printers, Zebra printers, scanners, and other computer peripherals. Provide out-of-the-box calibration and troubleshoot daily issues.
- Audio/Video conference room equipment, telephone systems, meeting software, messaging, and collaboration tools. Provide Conference room
- The MS365 suite includes SharePoint, permissions, and access management.
Qualifications
- Between 2-5 years experience in an IT support role
- Between 1- 3 years of managing IT systems in a laboratory setting in the pharmaceutical and biotechnology industry
- Documented experience in supporting Laboratory Information Systems preferred.
- Knowledge and experience with GMP, quality systems and regulatory standards requirements in the pharmaceutical and biotechnology
- Able to don cleanroom garments and personal protective equipment (scrubs, gowning coverall, sterile boots, masks, gloves, goggles) aseptically and work in a clean room environment for extended periods of time.
- Strong Microsoft Office skills (Outlook, Word, Excel, PowerPoint, etc.).
- Strong Break / Fix skills with desktops, workstations, notebooks, printers and handhelds.
- Broad experience of IT with strong understanding of networks, servers and telecoms.
- Ability to provide consistent, excellent customer service to entire staff, representing a variety of personalities and management levels.
- Excellent written, verbal communication skills and presentation skills.
- Must have the ability to mentor or share best practices with other members of the team.
- Must be detail oriented and self-motivating.
- The ability to work in a flexible, team-oriented environment is required.
- Working knowledge of IT Service Management framework and/or ITIL concepts and practices.
- Ability to lift/move computer equipment weighing up to 50 Lbs.
- Ability to work on flexible hours to support business needs.
- DesiredValidation experience to FDA CFR 21 Part 11 requirements. Ability to support a GxP environment with related GMP procedures.
- Have an understanding of Network devices such as routers and switches, firewalls, racks, and cabling.
- Preferred/Desirable Knowledge, Skills, and EducationCollege degree: BS in Computer Science or Information Systems.
- 2-3 years experience supporting IT/Lab Automation Equipment and applications
- Work on shift/On call basis as needed
- Physical Demands and Activities RequiredMust be able to remain in a stationary position, standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 50 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to prepare and analyze data and figures, view a computer screen, and read extensively.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
