CSV Specialist - IT​/Automation System Upgrades

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We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

This is an onsite position in Clayton, NC. Candidates must be authorized to work for any employer in the United States without visa sponsorship.

• Plan and execute validation activities for system upgrades, patches, new deployments, and configuration enhancements.
• Develop and maintain CSV documentation, including:
• Validation Plans
• User Requirements (URS) and Functional Specs (FS)
• Traceability Matrices
• Test Protocols (IQ/OQ/PQ) and Data Integrity Assessments
• Validation Summary Reports (VSR)
• Apply GAMP 5 and data integrity principles (ALCOA+) across all validation deliverables.
• Ensure compliance with 21 CFR Part 11 and Annex 11 requirements.
• Operate Client ALM for qualification testing, documenting test results and tracking progress, deviations, and defects.
• Collaborate with Quality to review and close discrepancies and change controls.
• Support periodic review and re-validation strategies for CSV‑maintained systems.
• Work closely with vendors and automation SMEs on system changes for Delta
  
  V, Syncade MES, Siemens Desigo CC, and Aveva OSI PI platforms, assessing GMP impact and supporting system hardening, backup/restore testing, and validated state lifecycle maintenance.
• Participate in project planning, FAT/SAT testing, and system handovers, providing CSV input to change control, risk assessments, and configuration documentation.

• Bachelor's degree in Engineering, IT, Computer Science, Life Sciences, or related field.
• 3+ years of CSV experience within regulated (GMP) environments.
• Hands‑on validation experience with Client ALM.
• Experience supporting upgrades or implementations of one or more of the following system types:
  Delta
  
  V, Syncade MES, Siemens Desigo CC, Aveva OSI PI.
• Knowledge of 21 CFR Part 11 Annex 1, GAMP 5, and Data Integrity expectations (ALCOA+).
• Basic understanding of automation architectures and IT infrastructure.
• Strong organizational skills, attention to detail, excellent communication and document‑writing abilities.
• Comfortable working in a fast‑paced project environment with multiple priorities.

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job; it's your opportunity to make a meaningful difference. You'll help shape the future of healthcare and technology, working alongside a purpose‑driven team that's as ambitious as it is supportive.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.