Senior IT, Technical Services Specialist

Alkermes • Waltham, MA

3d • Hybrid

About The Position

The Senior IT, Technical Services Specialist supports technology implementation, system maintenance, and production operations to ensure reliable, secure, and compliant performance of GMP and GxP systems. This role contributes to the development and execution of SOPs aligned with GMP guidelines, assists with onboarding and validating new equipment, and helps maintain the compliance and lifecycle management of existing systems. This position plays a key role in implementing new IT GxP solutions such as Data Historian and LIMS, by technically leading, performing system configuration, testing, documentation, and user support activities. Working closely with CMC, quality, and regulatory teams, the analyst ensures that system operations align with FDA and global regulatory expectations while supporting continuous improvement and operational excellence. Success in this role requires strong technical expertise in pharmaceutical manufacturing systems, a solid understanding of regulatory compliance requirements, and the ability to troubleshoot, integrate, and support complex IT solutions within a GMP environment.

Requirements

• Strong technical expertise in pharmaceutical manufacturing systems.
• Solid understanding of regulatory compliance requirements.
• Ability to troubleshoot, integrate, and support complex IT solutions within a GMP environment.

Responsibilities

• Supports technology implementation, system maintenance, and production operations to ensure reliable, secure, and compliant performance of GMP and GxP systems.
• Contributes to the development and execution of SOPs aligned with GMP guidelines.
• Assists with onboarding and validating new equipment.
• Helps maintain the compliance and lifecycle management of existing systems.
• Technically leads, performs system configuration, testing, documentation, and user support activities for new IT GxP solutions such as Data Historian and LIMS.
• Ensures system operations align with FDA and global regulatory expectations.
• Supports continuous improvement and operational excellence.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed