What are the responsibilities and job description for the Senior Computerized System Validation (CSV) Consultant- Indianapolis, US-Onsite position at Tech Rakers?
Job Details
Job: Senior Computerized System Validation (CSV) Consultant
Location: Indianapolis, US-Onsite
Duration: 12 Months
Job Summary:
We are seeking an experienced Senior Computerized System Validation (CSV) Consultant to lead validation strategy, ensure compliance with regulatory standards, and manage validation teams within a GXP and GMP-regulated pharmaceutical manufacturing environment. The ideal candidate will have extensive experience in Manufacturing Execution Systems (MES), Delta V, and laboratory system validation, with strong leadership and project management skills.
Required Qualifications & Experience:
- Bachelor s degree in Computer Science, Engineering, or a related field.
- Extensive experience in Computerized System Validation (CSV) for IT systems in Life Sciences, with a deep understanding of regulatory frameworks (GXP, GMP, GAMP 5, FDA 21 CFR Part 11, EU Annex 11).
- Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for systems such as MES, Delta V, laboratory systems, and ERP systems.
- Strong knowledge of pharmaceutical or biologic manufacturing processes, equipment, and regulations.
- Experience conducting risk assessments, impact analyses, and validation lifecycle management.
- Ability to manage multiple projects and lead validation teams, ensuring strict adherence to regulatory and business requirements.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Detail-oriented mindset with a focus on accuracy, compliance, and documentation in a regulated environment.
Ability to manage project budgets, resources, and validation timelines while ensuring compliance and operational efficiency.
Key Responsibilities:
- Develop and manage CSV strategy and execution for IT systems used in pharmaceutical manufacturing, including MES, Delta V, and laboratory systems.
- Lead and manage a team of CSV engineers, providing guidance and oversight on validation projects.
- Ensure regulatory compliance with GMP, GXP, GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.
- Define and implement risk-based validation approaches, assessing system risks, critical functions, and mitigation strategies.
- Develop, review, and execute validation protocols (IQ, OQ, PQ) to ensure system reliability, data integrity, and regulatory compliance.
- Collaborate with cross-functional teams (IT, Quality Assurance, Manufacturing) to align validation activities with business and regulatory requirements.
- Prepare and maintain validation documentation, including validation plans, reports, traceability matrices, and SOPs.
- Conduct internal audits and support regulatory inspections, ensuring compliance with industry standards.
- Provide training and mentorship to junior validation engineers and cross-functional teams on CSV best practices and compliance requirements.
- Manage project timelines, budgets, and resources to ensure timely delivery of validation activities.
Preferred Qualifications & Certifications:
- GAMP 5
- PMP (Project Management Professional) Certification (preferred)
Technical Expertise:
- Manufacturing Execution Systems (MES)
- Delta V & Distributed Control Systems (DCS)
- Laboratory Information Management Systems (LIMS)
- ERP Systems Validation
- Electronic Document Management Systems (EDMS)
- 21 CFR Part 11 Compliance & Data Integrity
Risk Assessment & Failure Mode Effect Analysis (FMEA)
