Valpro
pharmaceutical
AutomationQAEngineer
Neural analysis suggests this role is
optimal for Mid candidates.
“Automation QA Engineer at Valpro. Skills: Automation QA, Validation, GMP. 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”
Industry & Context.
Candidates must be legally eligible to work in the United States without company sponsorship, not interested in working on a corp-to-corp basis with other companies at this time
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, Ability to work independently in a remote environment, Candidates must be legally eligible to work in the United States without company sponsorship
Nice to Have
Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field, Syncade experience is a plus, Experience with one or more of the following is highly preferred: DeltaV Rockwell / PLC systems SCADA or HMI platforms MES systems Historian systems Automated manufacturing equipment within pharmaiotech environments
What You'll Do.
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
and 21 CFR Part 11 requirements
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 to ensure compliant execution of project deliverables
Communication Scope
Excellent communication and cross-functional collaboration skills
Process & Methodology
large-scale capital and operational projects
Full Job Description
Valpro has several available opportunities supporting our world-class client sites or partner organizations. Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below. 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 quality assessments Support audit readiness and inspection preparedness activities Assist with implementation and continuous improvement of validation and QA processes Preferred Systems / Technologies Experience with one or more of the following is highly preferred: DeltaV Rockwell / PLC systems SCADA or HMI platforms MES systems (Syncade experience is a plus) Hist
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