CSV Engineer

Job Title: CSV Engineer Location: Pittsburgh, PA (Onsite)

Experience: 5 - 8 Years Employment Type: Full-Time

Overview We’re seeking an experienced Computer System Validation Engineer to join a growing leader in the pharmaceutical and biotechnology sector. This role will lead the implementation and validation of GxP computerized maintenance systems—particularly CMMS platforms like Blue Mountain—while ensuring compliance with regulatory and data integrity standards.

Key Responsibilities

Author, review, and execute validation deliverables, including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, and Summary Reports.

Lead validation activities for GxP computerized systems such as CMMS, BAS, EMS, and SCMS in compliance with 21 CFR Part 11, Annex 11, GAMP 5, and ALCOA+ principles.

Apply risk-based validation methodologies to ensure systems meet regulatory requirements and data integrity expectations.

Collaborate with QA, IT, Engineering, and Facilities teams to drive validation readiness and timely execution.

Manage the validation lifecycle using Kneat or similar platforms, maintaining traceability, audit readiness, and compliance with change control and deviation processes.

Qualifications

• 5–8 years of experience in Computer System Validation (CSV) or Computer Software Assurance (CSA) within pharmaceuticals, biotechnology, or other regulated life sciences industries.

• Proven expertise in qualifying GMP computerized systems (e.g., CMMS, BAS, EMS, SCMS) with a strong understanding of data integrity requirements.

• In-depth knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and related regulatory guidelines.

• Demonstrated ability to author and execute validation protocols, test scripts, and technical documentation.

• Strong organizational skills and ability to collaborate across functions.

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related technical field.