IT Operations Manager for FDA-Regulated Systems

SHARP STERILE MANUFACTURING LLC; Lee (MA); On-site; USD 95,000 - 140,000; Full time

Job summary

SHARP STERILE MANUFACTURING LLC in Lee, MA, is seeking an IT Manager to lead IT staff and the BSM help desk, ensuring reliable network applications and systems for a GMP environment.

The role focuses on system administration, vendor coordination, SOP development, and maintaining security/compliance with FDA regulations, while mentoring technicians and guiding IT projects within a fast-paced manufacturing setting.

Qualifications

• Bachelor's degree or equivalent education and experience.
• Four years related technology experience; regulatory experience preferred.
• Experience in a cGMP or FDA-regulated environment is a plus.
• Proficiency with Microsoft Office suite and Windows OS required.
• Familiarity with Active Directory, Azure, Exchange, and Teams preferred.

Responsibilities

• Resident SME for information technology and solutions.
• Manage help desk through support ticket generation, tracking and resolution.
• Coordinate activities with technology vendors and contractors to design, set up or troubleshoot systems.
• Maintain organized records of company technology related documents, software licenses and equipment.
• Continuously strive to improve the company computerized systems with focus on quality, timeliness and cost-awareness.
• Administrative ad hoc review of reports and management of records.
• Adopt SOPs and develop plant-specific IT SOPs.
• Act as system administrator for plant systems.
• Create and perform training with employees on IT topics.

Skills

Proficient at troubleshooting

Well-organized

Attention to detail

Professional communication

Education

Bachelor's degree or equivalent education and experience

Tools

MS Office

Word

Excel

PowerPoint

Outlook

Windows OS

Active Directory

Azure

MS Exchange

MS Teams

RJ45 wiring

SQL databases

Job description

SHARP STERILE MANUFACTURING LLC in Lee, MA, is seeking an IT Manager to lead IT staff and the BSM help desk, ensuring reliable network applications and systems for a GMP environment.

The role focuses on system administration, vendor coordination, SOP development, and maintaining security/compliance with FDA regulations, while mentoring technicians and guiding IT projects within a fast-paced manufacturing setting.