Valpro

Role Description 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) - Historian systems - Automated manufacturing equipment within pharma/biotech environments Qualifications - Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field preferred - 3+ years of experience in Automation QA, CSV, CQV, or Validation within the pharmaceutical, biotech, or regulated manufacturing industry - Strong 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 Benefits - Flexible career options - Paid time off - Paid holidays - Medical - 401K match - Other unique incentives Company Description Valpro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.