Senior CSV Automation Lead

Intellectt INC

Job Title: Senior CSV Automation Lead

Location: Bend, OR
Employment Type: Contract
Duration: 12 Months + Extensions
Salary: $50-$67/hr on W2

About the Role

We are seeking an experienced Senior CSV Automation Lead to support a large-scale CAPEX project within a regulated pharmaceutical/biotechnology manufacturing environment.

The role will lead Computer System Validation activities for complex manufacturing automation and computerized systems, working across engineering, automation, manufacturing, quality, and IT/OT teams from system design through implementation and qualification.

Key Responsibilities

Lead CSV activities for automation and computerized manufacturing systems throughout the system lifecycle.

Develop and execute validation strategies, plans, protocols, reports, and supporting documentation.

Support validation of SCADA, PLC, MES, and other automation-related systems.

Work closely with engineering and automation teams during system design, implementation, commissioning, and qualification.

Support Allen-Bradley PLC and Emerson Syncade MES validation activities.

Ensure computerized systems meet applicable GMP, regulatory, data integrity, and business requirements.

Review system specifications, requirements, design documentation, and validation deliverables.

Coordinate with Quality, Manufacturing, Engineering, Automation, and IT/OT teams to resolve validation issues and maintain project timelines.

Provide hands-on technical leadership while working independently in a fast-paced CAPEX project environment.

Required Qualifications

Strong experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, or other regulated manufacturing environments.

Hands-on experience with automation, SCADA, and PLC systems.

Strong knowledge of Allen-Bradley PLCs.

Experience with Emerson Syncade MES.

Experience leading validation activities from design through implementation, commissioning, and qualification.

Strong understanding of GMP, computerized system compliance, and data integrity requirements.

Experience working with Engineering, Automation, Manufacturing, Quality, and IT/OT teams.

Strong communication, documentation, and project leadership skills.

Ability to work independently and lead complex validation activities.

Benefits

This is a contract position and does not include employer-provided benefits.

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check

Background checks may be conducted in accordance with applicable law.

Apply

Vacancy posted 2 days ago

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