Piper Companies is searching for an experience CSV Engineer to join a growing leader in the pharmaceutical/biotechnology space for an onsite position in Pittsburgh, PA. The CSV Engineer will lead the implementation and validation of computerized maintenance systems—particularly CMMS platforms like Blue Mountain—ensuring compliance with regulatory and data integrity standards.

QUALIFICATIONS FOR THE CSV ENGINEER INCLUDE:

• 5–8 years of experience in Computer System Validation (CSV) or Computer Software Assurance (CSA) within pharmaceutical, biotech, or other regulated life sciences industries.
• Proven expertise in qualifying GMP computerized systems such as CMMS, BAS, EMS, and SCMS, with a strong grasp of data integrity and compliance requirements.
• Thorough understanding of GAMP 5, risk-based validation methodologies, and regulatory frameworks including 21 CFR Part 11 and Annex 11.
• Skilled in authoring and executing validation protocols, test scripts, and technical documentation, with strong organizational and cross-functional collaboration abilities.
• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related technical discipline.

• Author, review, and execute validation deliverables including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, and Summary Reports.
• Support the validation of GxP computerized systems such as CMMS, BAS, EMS, and SCMS, ensuring compliance with regulatory and data integrity standards.
• Apply GAMP 5 and risk-based validation principles to ensure systems meet 21 CFR Part 11, Annex 11, and ALCOA+ requirements.
• Collaborate with cross-functional teams including QA, IT, Engineering, and Facilities to drive validation readiness and execution.
• Manage validation lifecycle activities using Kneat or similar platforms, ensuring traceability, audit readiness, and support for change control and deviation processes.