Digital Capability Manager – Syracuse IT
About the Job
The Digital Capability Manager is a key member of the site BMS IT team supporting systems primarily at the Syracuse manufacturing plant. The role is generally responsible for administering, providing project support for system lifecycle management, addressing user problems and responding to audits.
This role will initially focus on administration of laboratory and floor computer systems and computer system validation lifecycle management.
Role is for an individual contributor. Demonstrated leadership skills required.
Role will by supported by consultants and contract personnel as needed.
Key business partners include Syracuse Quality Labs and Manufacturing Operations, Syracuse Quality teams, Infrastructure teams, Corporate IT teams, Site and Corporate Quality teams
- Provide system lifecycle support for IT systems used by the site whether locally hosted or hosted elsewhere. This position will initially focus on laboratory and manufacturing floor computers.
- Supporting IT projects, as a team member by providing site perspective and helping to minimize impact on ongoing operations.
- Providing development, administration and user management for site IT systems
- Ensuring site IT systems are complaint to BMS policies, Sarbanes-Oxley, FDA 21 CFR 11 and EU Annex 11 requirements, etc.
- Providing on-call support as needed for 24/7 commercial operations
- Work closely with Corporate IT, Site Automation, Validation and Quality Control teams, other BMS internal resources & external engineers, contractors and suppliers.
- As a member of the Global IT organization, opportunities may arise to support applications at other BMS or partner sites. Occasional, possibly international travel may be required.
- BS or equivalent experience in Computer Science, Engineering, Chemistry, Biology or related technical field.
- 1-3 years of pertinent experience
- Demonstrated experience working in regulated environment governed by multiple Regulatory Agencies (such as FDA, EMEA) and internal BMS requirements. Knowledge should include 21 CFR Part 11, Computer System Validation, and cGMP/cGLP regulations.
- General IT-related knowledge and experience with tools such MS Windows O/S, MS SQL Server Database, Oracle Database, and MS SharePoint.
- Excellent written and verbal communication skill are required. Must be a hands-on individual, willing to take initiative.
- Experience with server/PC configuration and network architectures.
- Experience with cyber security and user management
Ideal Candidates Would Also Have\:
- Demonstrated experience with\:
- Emerson’s Syncade Document Control & Archival system
- Sparta’s TrackWise quality management systems
- OSI’s PI historian
- Water’s Empower and NuGenesis systems
- Knowledge of biologics manufacturing processes, Knowledge of laboratory processes