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 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
