Duties and Responsibilities

• Acts as administration and end user support for systems such as ELN, Waters CDS, LIMS, etc.
• Maintains primary point of contact between users, internal IT and vendors
• Coordinates and oversees vendors and service providers
• Supports lifecycle management of lab systems
• Works with management and subject matter experts to improve, develop and test existing applications and systems
• Identifies and drives enhancements to existing systems and processes
• Supports qualification activities such as drafting, executing and or reviewing IOP/Q documentation
• Drafts SOP’s for SME review
• Manages and or supports system and data backups for all OT system
• Ensures security, compliance and integrity of all data        
• Identifies and supports implementation of engineering-based improvements or upgrades in small to medium scope and complexity
• Supports vital commissioning and qualification of systems is completed in alignment with site GMP requirements
• May interact with regulatory inspectors as necessary
• Provides troubleshooting support to reduce production downtime
• Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies 
• Participates in process improvement and other non-routine projects
• Regularly interfaces with department stakeholders on technical and coordinative matters  
• Demonstrates cross-functional support capabilities with other teams 
• Adheres to consistent and predictable in-person attendance
• Responsibilities may increase in scope to align with company initiatives
• Performs other related duties as assigned

Required Skills and Abilities

• Strong working knowledge of on-premises and cloud-based IT infrastructures and operations best practices
• Excellent working knowledge of computer systems, network and systems administration, data storage systems, and security
• Excellent verbal, written, and interpersonal communication skills
• Ability to work independently or as a contributing team member
• Strong analytical and problem-solving skills
• Strong project management skills
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company 
• Follow detailed written and oral instructions 
• Demonstrates ability to collaborate and work in cross-functional teams. 
• Excellent organizational skills and attention to detail
• Strong time management skills with a proven ability to meet deadlines
• Multitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption and/or unexpected needs 
• Accepts feedback from a variety of sources and constructively manages conflict  
• Ability to prioritize tasks and to keep leadership apprised of performance to timelines
• Proficient with Microsoft Office Suite or related software

Education and Experience

• Bachelor’s degree in information technology, Computer Science, Informatics, Chemistry or related field preferred
• Combination of equivalent certification and experience accepted
• Requires 3 years of GMP experience 
• Extensive experience with CDS, LIMS, ELN, and related applications such as Open Labs, Empower, Tiamo, etc. 
• Experience leading and managing IT/OT projects such as infrastructure and or software deployments
• Working knowledge of and experience with relational database systems such as Oracle, MS-SQL, MySQL, etc.
• Working experience with industry-related standards and regulations such as FDA 21 CFR-11, GAMP5, ALCOA+, etc. 

Physical Requirements

• Prolonged periods of sitting or standing at a desk and working on a computer 
• Must be able to demonstrate mobility throughout multiple campus buildings   
• Must be able to lift up to 15 pounds at times routinely, 30 pounds occasionally.   
• Installing and monitoring equipment requires reaching overhead, kneeling, and crouching