IT Manager
SHARP STERILE MANUFACTURING LLC
- Location
- Onsite (Lee, Massachusetts)
- Compensation
- $95k - $140k/yr
- Employment
- Full-time
- Level
- Mid Level
Posted 1 week ago
About the role
Sharp Sterile Manufacturing is a contract manufacturer of sterile injectables seeking an IT Manager to oversee IT staff, help desk operations, and plant systems. The role ensures network applications and systems are efficient and compliant with FDA regulations.
Skills
IT Management
Help Desk Management
Network Administration
System Administration
Troubleshooting
Active Directory
Azure
MS Exchange
MS Teams
SQL
cGMP
FDA Regulations
21 CFR Part 11
Technical Training
Vendor Management
Low Voltage Wiring
Full job details
Position Summary
The IT Manager will manage IT staff and the BSM help desk by providing technical advice and oversight for network applications for both new and existing systems at BSM.
Duties and Responsibilities
- Resident SME for information technology and solutions
- Manage help desk through support ticket generation, tracking and resolution
- Coordinating activities with technology vendors and supporting technology contractors to design, setup or troubleshoot systems
- Maintain organized records of company technology related documents, software licenses and computerized equipment
- Continuously strive to improve the company computerized systems with a focus on quality, timeliness and cost-awareness
- Administrative ad hoc review of reports and management of records
- Adopt corporate policies and standard operating procedures (SOPs) and develop plant specific SOPs for all IT activities
- Act as system administrator for plant systems
- Create and perform training with employees on IT related topics (account security, application troubleshooting, new user training, etc.)
- Manage quality change controls, CAPAs, deviations, events related to IT
- Other duties as assigned
Regulatory Responsibilities
- Monitor and control security of company computerized systems, assess 21 CFR Part 11 compliance and respond with necessary corrective actions
- Ensure BSM IT/IS systems are operating efficiently and in compliance with FDA regulations and BSM approved procedures
Supervisory Responsibilities
- Oversee day to day activities and training of the IT group
- Provide leadership to maintain and improve BSM technology
- Provide guidance and mentorship to IT technicians
Experience
- Four (4) years related technology experience or combination of education and work experience
- One (1) year experience in cGMP and/or FDA regulated industry
- IT related certifications preferred
Education
- Bachelor’s degree or equivalent education and experience
Knowledge, Skills & Abilities
- Proficient in MS Office applications (including Word, Excel, Powerpoint and Outlook), Windows OS, basic networking devices
- Familiarity with Active Directory, Azure, MS Exchange, MS Teams is required
- Knowledge of RJ45 wiring required
- Good customer service skills
- Familiarity with databases and SQL software is preferred
- Well-organized
- Proficient at troubleshooting
- Attention to detail while executing multiple tasks, maintaining accurate records and files
- Ability to manage timelines to meet assigned goals
- Maintain control and confidentiality of documents and information
- Demonstrated effective management of small teams
- Ability to communicate in a professional manner and work in a fast-paced environment
Physical Requirements
- Use of standard office equipment with or without reasonable accommodation(s)
- Ability to remain stationary for prolonged periods of time
- Walk between work areas
- Lift up to 10lbs. frequently and up to 50 lbs. occasionally
- Perform low voltage wiring and wire running in confined areas