Sr. Architect

Job Title :

Sr Lab System Support Engineer Location :

West Point, PA - onsite

Duration :

6.5 months Job Description/ Responsibilities Job Summary Sr Lab System Support Engineer plays a key role in supporting laboratory operations by ensuring the smooth functioning of lab systems, analytical instruments, and data workflows. This entry-level position is ideal for candidates with a background in life sciences or IT who are eager to work in a regulated pharmaceutical environment.

Must Have's:

1. Lab system life cycle management 2. Lab system vendor handling 3. Lab system business processes understanding in pharmaceutical regulatory environment

Roles & Responsibilities Lab System Lifecycle Management:

Manage end to end lab system lifecycle including implementation validation maintenance and decommissioning Ensure compliance with

SDLC CSV

GxP and regulatory standards Handle system upgrades patching backup archival and audit readiness

Lab System Vendor Handling:

Act as point of contact for vendors for installation support and issue resolution Coordinate maintenance upgrades and ensure SLA and regulatory compliance Manage vendor deliverables documentation and escalation handling Lab System Business Process Understanding in Pharmaceutical Regulatory Environment. Understand lab workflows and align systems with business and regulatory requirements. Ensure compliance with GLP GMP GxP and data integrity standards Collaborate with QA IT and lab teams to support audits and process improvements Key Skills & Expertise

• Good Knowledge and understanding on the GXP.
• Good knowledge of Computer System Validation.
• Good understanding of laboratory instruments and analytical techniques.
• Familiarity with lab software systems.
• Strong problem-solving and communication skills.
• Ability to work in a regulated environment and follow SOPs.
• Good Knowledge of Ticketing systems (ServiceNow/Remedy etc)
• Good Knowledge on the Problem/Deviation/Change/CAPA Management Process.

Job Duties:

• Provide first-level hands & feet support for laboratory software systems and instrument integration platforms.
• Oversee daily lab activities including scheduling, equipment maintenance, and workflow optimization.
• Act as a liaison between the lab and external entities (e.g., regulatory bodies, partner institutions).
• User Management Activities (E.

g:

User Creation, Modification & Deletions etc.)

• Hardware related PC/Network - Coordination with Desktop support team
• Vendor communications, coordination during the System Hardware failures & any other Maintenances
• Backup of the Standalone and Benchtop systems on regular basis
• Application Software upgrades on the standalone systems.
• Onboarding and off boarding Lab systems
• Monthly patching coordination.
• Backup & Restoration for the Lab systems
• Lac/es Configuration
• Update SOPs/ WIs
• Assist in troubleshooting software and hardware issues related to lab instruments (e.g., HPLC, GC, spectrophotometers).
• Ensure accurate documentation of system configurations, user guides, and troubleshooting procedures.
• Help maintain audit trails and support data archival processes.
• Support compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and FDA regulations.
• Ensure systems are validated and maintained according to SOPs and validation protocols.
• Work closely with lab analysts, QA, and IT teams to resolve system-related issues.
• Participate in cross-functional meetings to improve lab workflows and system performance.
• Support Audits Queries from the LAB IT side.

Education:

• Bachelor's degree in Life Sciences, Chemistry, Biology, Computer Science, or related field.
• 8+ years of experience in a laboratory or IT support role.

Years of Experience:

11.00 Years of Experience