CSV Engineer

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Description

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

About Alliance Biotech Solutions Alliance Biotech Solutions (ABS) is a premier consulting firm specializing in biopharmaceutical engineering and validation services. As industry leaders in Commissioning, Qualification, and Validation (CQV), we provide crucial services to the biotech and pharmaceutical sectors while maintaining our philosophy that employees are our #1 priority. Our success is built on the foundation of empowering our team members' growth and development, recognizing that our employees are the cornerstone of our clients' success. Alliance Biotech Solutions is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation. Alliance Biotech Solutions does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Alliance Biotech Solutions, and Alliance Biotech Solutions will not be obligated to pay a placement fee. All persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.