Alliance Biotech Solutions is seeking a mid-to-senior-level CSV Engineer to support a biotechnology client transitioning GMP manufacturing operations to a new facility. The primary assignment involves the compliant decommissioning of approximately five manufacturing-related computerized systems, including Enterprise Management Systems (EMS), Building Management Systems (BMS), and bioreactor control applications. The engineer will own CSV documentation and coordinate with Engineering, IT/OT, Manufacturing, and Quality; physical equipment removal is handled separately by Engineering.
Requirements
• Develop and execute risk-based CSV decommissioning protocols, assessments, and final reports for GMP computerized systems.
• Ensure appropriate data retention, audit trail preservation, record accessibility, and documented system disposition.
• Support validation impact assessments for GMP systems being relocated, including applications hosted on virtualized infrastructure.
• Provide ongoing CSV support for change controls, application upgrades, periodic reviews, and maintaining validated systems.
Experience & Skills
• Mid-to-senior-level CSV experience in pharmaceutical or biotech GMP environments, ideally with manufacturing and laboratory computerized systems.
• Exposure to OT-facing applications such as EMS, BMS, bioreactors, chromatography skids, or related manufacturing control systems.
• Hands-on experience authoring validation documentation and working with GAMP 5, 21 CFR Part 11, GMP data integrity, and risk-based validation.
• Ability to manage deliverables independently and collaborate effectively with cross-functional technical and Quality teams. Prior GMP system decommissioning experience is strongly preferred.
Benefits & Compensation
• Industry competitive wage as a full-time employee
• Flexible Paid Time Off
• Bonus plans
• Medical, Dental and Vision Insurance with low employee cost
• Employer paid long term and short-term disability
• 401k plan with employer contributions
