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Serán BioScience

CDMO · drug formulation development

Operational Technologies Specialist

United States · OnsitePosted 2 months ago
InfrastructureUnspecifiedFull Time Exempt
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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

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