Company

IT

OperationalTechnologiesSpecialist

$85–125k ~AI est. Bend, Oregon, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“Operational Technologies Specialist. Skills: System administration, Data integrity, cGMP compliance. Administer systems. Provide end user support”

What You'll Achieve.

Reduce production downtime

Industry & Context.

IT
Problems you'll solve

Analytical skills; Problem-solving skills

Eligibility Requirements

Lift up to 15 pounds, Lift 30 pounds occasionally, Reaching overhead, Kneeling, Crouching

What They're Looking For.

Must Have

Minimum 3 years of GMP experience, Extensive experience with CDS, LIMS, ELN, Experience leading and managing IT/OT projects

Nice to Have

Working knowledge of relational database systems, Working experience with industry-related standards and regulations

What You'll Do.

Provide end user support

Support manufacturing systems

Drive enhancements to systems

Drive enhancements to processes

Support qualifications activities

Draft IOP/Q documentation

Execute IOP/Q documentation

Review IOP/Q documentation

Manage system backups

Support system backups

Ensure security of data

Ensure compliance of data

Ensure integrity of data

Support commissioning of systems

Support qualification of systems

Reduce production downtime

Adhere to Standard Operating Procedures

Adhere to Quality Manual

Adhere to company policies

Participate in process improvement

Participate in non-routine projects

Interface with department stakeholders

Provide cross-functional support

Coordinate service providers

Oversee service providers

How You'll Work.

Team & Collaboration

Cross-functional teams; Department stakeholders; Other teams

Communication Scope

Verbal communication; Written communication; Interpersonal communication; Effective communication

Process & Methodology

Project management, IT/OT projects

Full Job Description

## 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 organization

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