Piper Companies is actively seeking a CSV (Computer System Validation) Engineer. The ideal candidate will have 5–8 years of experience in validating GxP computerized systems such as CMMS, BAS, SCMS, and EMS. This role is critical to ensuring compliance with global regulatory standards and ElevateBio’s internal validation policies. This is a Monday–Friday, traditional hours role located onsite in Pittsburgh.

QUALIFICATIONS OF THE CSV ENGINEER:

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
• 5–8 years of CSV/CSA experience in pharmaceutical, biotech, or regulated life sciences industries.
• Strong understanding of GAMP 5, risk-based validation, and data integrity principles.
• Experience qualifying CMMS, BAS, EMS, and/or SCMS in GMP environments.
• Proficient in writing and executing validation protocols and technical documentation.
• Excellent communication, organizational, and cross-functional collaboration skills.

Preferred Experience:

• Hands-on experience with Kneat or similar e-validation lifecycle tools.
• Exposure to cell and gene therapy or sterile drug product manufacturing.
• Experience with greenfield or brownfield startup validation projects.
• Familiarity with 21 CFR Part 11, EU Annex 11/15, and other international regulatory guidelines.

• Author, review, and execute CSV deliverables including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, and Summary Reports.
• Support validation of GxP computerized systems including:
• CMMS (e.g., BMRAM R3/4)
• Building Automation Systems (BAS)
• Environmental Monitoring Systems (EMS)
• Sterile Control Monitoring Systems (SCMS)
• Ensure systems are validated in accordance with GAMP 5 and compliant with 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
• Collaborate with QA, IT, Engineering, Facilities, and CQV partners to drive validation readiness and execution.
• Manage validation lifecycle activities using Kneat or equivalent e-validation platforms.
• Support change control, deviation investigations, and impact assessments related to validated systems.
• Maintain audit-readiness and ensure traceability of validation activities.