Valspec

Life Sciences

AutomationQAEngineer

Non-Headquarters CONTRACT Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“Automation QA Engineer at Valspec. Skills: Automation QA, GMP, Validation. Provide QA oversight and support for automation-related qualification and validation activities. Review and approve validation lifecycle documentation”

Industry & Context.

Life Sciences
Eligibility Requirements

Must be legally eligible to work in the United States without company sponsorship

What They're Looking For.

Must Have

3+ years of experience in Automation QA, CSV, CQV, or Validation within the pharmaceutical, biotech, or regulated manufacturing industry, understanding of GMP compliance and validation lifecycle principles, Experience reviewing and approving GMP documentation, Familiarity with data integrity and 21 CFR Part 11 requirements, Excellent communication and cross-functional collaboration skills, Ability to work independently in a remote environment, Legally eligible to work in the United States without company sponsorship

Nice to Have

Experience with DeltaV, Experience with Rockwell / PLC systems, Experience with SCADA or HMI platforms, Experience with MES systems, Syncade experience, Experience with Historian systems, Experience with Automated manufacturing equipment within pharma/biotech environments

What You'll Do.

Provide QA oversight and support for automation-related qualification and validation activities

Review and approve validation lifecycle documentation

Support automation systems operating within GMP manufacturing environments

Ensure compliance with FDA

and 21 CFR Part 11 requirements

Partner with Automation

Participate in document reviews

and quality assessments

Support audit readiness and inspection preparedness activities

Assist with implementation and continuous improvement of validation and QA processes

How You'll Work.

Team & Collaboration

Working cross-functionally with Validation, Engineering, Manufacturing, and Quality teams; Partner with Automation, CQV, CSV, Manufacturing, and Quality teams

Communication Scope

Excellent communication skills

Full Job Description

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies. Automation QA Engineer Location: Remote Employment Type: Contract / Consulting (6-12+ months) Start Date: ASAP About the Role: We are seeking experienced Automation QA Engineers to support our clients in North Carolina. These roles will support automation quality assurance activities within a GMP-regulated pharmaceutical manufacturing environment, with a strong focus on commissioning, qualification, validation, and lifecycle documentation for automation systems. This is an excellent opportunity for candidates with pharmaceutical or biotech automation QA experience who are comfortable working cross-functionally with Validation, Engineering, Manufacturing, and Quality teams in support of large-scale capital and operational projects. Key Responsibilities Provide QA oversight and support for automation-related qualification and validation activities Review and approve validation lifecycle documentation including: IQ/OQ/PQ protocols and reports Risk assessments Traceability matrices Change controls Deviations and CAPAs Support automation systems operating within GMP manufacturing environments Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11 requirements Partner with Automation, CQV, CSV, Manufacturing, and Quality teams to ensure compliant execution of project deliverables Participate in document reviews, project meetings, and quali

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