CSV Consultant

Piper Companies is currently seeking a highly skilled Computer System Validation (CSV) Engineer to support our cell culture-based Drug Substance (DS) manufacturing operations in Raleigh, North Carolina (NC). This role is critical to ensuring compliance with regulatory standards and maintaining the integrity of automated systems used in upstream bioprocessing environments.

Responsibilities for the CSV Consultant:

• Lead and execute IQ/OQ/PQ protocols for manufacturing and laboratory systems.
• Validate bioreactor control systems, including platforms such as, Rockwell, Siemens, and SCADA.
• Ensure compliance with 21 CFR Part 11, GAMP 5, and GMP regulations.
• Support validation of single-use systems and hybrid platforms (e.g., FleXBatch).
• Collaborate with cross-functional teams including QA, IT, and Manufacturing to ensure seamless CSV execution.

 Qualifications for the CSV Consultant:

• Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
• 5+ years of experience in CSV within biotech or pharmaceutical manufacturing, preferably in cell culture-based DS environments.
• Strong knowledge of automation systems, MES, LIMS, and data integrity principles.
• Experience working in GMP-regulated environments and supporting biologics or API manufacturing.
• Excellent communication, documentation, and project management skills.

Compensation for the CSV Consultant:

• Salary Range: $150,000 - $175,000
• Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays