CSV Engineer

Piper Companies is seeking a 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.

Responsibilities of the CSV Engineer include:

• 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.

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.

 Compensation for the CSV Engineer:

• Salary Range: $75-$85/hour (USD)
• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 7/3. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: CSV Engineer, Computer System Validation, CSA, Computer Software Assurance, GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, data integrity, validation protocols, IQ OQ PQ, URS, risk assessments, validation plans, CMMS, Blue Mountain, BMRAM, BAS, Building Automation Systems, EMS, Environmental Monitoring Systems, SCMS, Sterile Control Monitoring Systems, GMP systems, GxP systems, pharmaceutical, biotech, life sciences, regulated industry, Kneat, electronic validation, validation lifecycle, GMP compliance, greenfield, brownfield, facility startup, QA collaboration, IT systems validation, engineering systems validation

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