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