CSV Specialist - IT/Automation System Upgrades

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. 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.

We are currently seeking a Computerized Systems Validation (CSV) Specialist for a 12 month project supporting computerized system upgrades and lifecycle validation activities for manufacturing automation, MES, building management, and data historian platforms in a regulated biopharmaceutical environment. The role ensures that all IT/Automation systems remain compliant with cGMP, 21 CFR Part 11, GAMP 5, and applicable data integrity requirements throughout design, configuration, testing, and deployment.

This individual will collaborate with IT, Automation, Quality, and Engineering teams to develop validation documentation, manage test execution, and ensure systems are released for GMP use in a timely and controlled manner.

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

Key Responsibilities

CSV & Compliance

• Plan and execute validation activities for system upgrades, patches, new deployments, and configuration enhancements.
• Develop and maintain CSV documentation including:

o Validation Plans

o Risk Assessments (FMEA/Part 11/Data Integrity)

o User Requirements (URS), Functional Specs (FS)

o Traceability Matrices

o Test Protocols (IQ/OQ/PQ), Data Integrity Assessments

o Validation Summary Reports (VSR)

o Apply GAMP 5 and data integrity principles (ALCOA ) in all validation deliverables.

o Ensure compliance with 21 CFR Part 11 and Annex 11 requirements.

o Testing & Client ALM Administration

o Execute and document qualification testing in Client ALM (required).

o Track test progress, deviations, and defects within ALM workflows.

o Partner with Quality to review and close discrepancies and change controls.

o Support periodic review and re-validation strategies for CSV-maintained systems.

Technical & System Focus

• Work closely with vendors and automation SMEs to understand system changes for:

o DeltaV - process control system upgrades and configuration changes

o Syncade MES - recipe, workflow, and unit procedure modifications

o Siemens PCS 7 - process automation enhancements

o Siemens Desigo CC - Client/Client upgrades for facilities and cleanrooms

o Aveva OSI PI - historian infrastructure and data model improvements

• Assess GMP impact for new functionality, system patches, and cybersecurity upgrades.
• Support backup/restore testing, system hardening, and validated state lifecycle maintenance.

Project Support

• Participate in project planning, FAT/SAT testing, and system handovers.
• Provide CSV input to change control, risk assessments, and configuration documentation.
• Contribute to schedule updates and progress reports with cross-functional team leads.

Qualifications

• Bachelor's degree in Engineering, IT, Computer Science, Life Sciences, or related field.
• 3 years in CSV within regulated (GMP) environments.
• Hands-on validation experience with Client ALM.
• Experience supporting upgrades or implementations of one or more of the following:
• DeltaV, Syncade, Siemens PCS 7, Siemens Desigo CC, 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

Soft Skills

• Strong organizational skills and attention to detail.
• Excellent communication and document writing abilities.
• Ability to interpret technical information and translate it into compliant documentation.
• 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.

Excited to build something meaningful together? We look forward to hearing from you!

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.