Job Description

Role: CSV Lead
Location: IN, CA, NC and DE (Multiple locations)

Required:

DeltaV and Rockwell

About the Project:

We are looking for an experienced Computer System Validation (CSV) Lead to oversee automation systems validation for utilities at a large-scale greenfield pharmaceutical manufacturing facility. This site will feature monoclonal antibody (mAb) and bioconjugate production, along with key infrastructure including a central utility plant (CUP), administration and laboratory buildings, and tank farm systems.

The CSV Lead will provide technical leadership and manage all CSV activities for automation systems related to utilities and supporting infrastructure, ensuring compliance with regulatory standards and project deadlines.

Key Responsibilities:

• Lead and manage CSV activities for automation systems supporting utilities such as CUP, tank farm, and administrative/laboratory systems.
• Develop and implement validation strategies, plans, and protocols (IQ, OQ, PQ) following GAMP 5 and regulatory guidelines.
• Oversee preparation and review of validation documentation including risk assessments, test scripts, and traceability matrices.
• Collaborate closely with automation engineers, quality assurance, and project management teams to ensure timely and compliant completion of validation activities.
• Maintain compliance with GMP, 21 CFR Part 11, and data integrity standards throughout the system lifecycle.
• Support audits and inspections related to CSV and automation compliance.

Qualifications:

• Bachelor's degree in Engineering, Computer Science, or related field.
• 8+ years of experience in computer system validation within pharmaceutical or biotech manufacturing.
• Deep knowledge of GAMP 5, 21 CFR Part 11, and data integrity principles .
• Proven experience validating automation platforms such as DeltaV and Rockwell and related infrastructure.
• Familiarity with electronic documentation and compliance systems such as Kneat.
• Experience with greenfield or large-scale capital projects is a plus.
• Understanding of utilities automation and control system architecture is beneficial.

Best Regards,

Satya Satish J | Technical Recruiter | IT Minds LLC |

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