Operational Technologies Specialist

Operational Technologies Specialist

Serán is seeking an Operational Technologies Specialist who will be responsible for the management, maintenance, and deployment of laboratory and manufacturing systems across both GMP-regulated and development environments. This role partners closely with IT, Quality Assurance (QA), laboratory staff, and manufacturing teams to ensure seamless integration of technology solutions that enhance productivity, quality, data integrity, and operational efficiency.

Duties and Responsibilities

• 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 deployments
• Working 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