Operational Technologies Specialist

Duties and Responsibilties

• Administration and end user support for systems such as FTIR, Waters CDS, ELN, various manufacturing equipment, etc.
• Primary point of contact between users, internal IT and vendors
• Support lifecycle management of lab and manufacturing systems
• Work with management and subject matter experts to improve, develop and test existing applications and systems
• Identify and drive enhancements to existing systems and processes
• Support qualifications activities such as drafting, executing and or reviewing IOP/Q documentation
• Drafting SOP’s
• Manage and or support system and data backups for all OT system
• Ensure security, compliance and integrity of all data
• Support vital commissioning and qualification of systems is completed in alignment with site cGMP requirements
• May interact with regulatory and or client inspectors as necessary
• Provide 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
• Coordinate and oversee vendors and service providers

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
• Demonstrated 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

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 minimum 3 years of GMP experience
• Extensive experience with CDS, LIMS, ELN, and related applications such as Empower, Tiamo, FTIR, Rockwell, etc.
• Experience leading and managing IT/OT projects such as infrastructure and or software deploymentsWorking knowledge of and experience with relational database systems such as Oracle, MS-SQL, MySQL, etc. preferred
• 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