Operations Technologies Specialist

Serán BioScience is looking for an Operational Technologies Specialist to join the Information Technology team. The primary responsibility of this role is to develop, deploy, and manage laboratory and manufacturing systems and solutions in both GMP-regulated and development environments. As a member of the IT Department, this position works with IT, laboratory and manufacturing personnel to ensure the seamless integration of technology solutions that enhance productivity, quality, security, and efficiency. To achieve these goals, ideal candidates will have a collaborative team spirit, the ability to manage their own projects and work independently, while having industry experience of regulatory standards. Those with laboratory and manufacturing system support experience within a GMP environment are encouraged to apply.

• 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

• 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

• 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. 

• 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 

Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Benefits Summary:

Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701