Lead Validation Engineer (CSV / DeltaV)

Hi,

My name is Sravani Dasari from Vakula Tech Inc. We are hiring talented professionals for our client. I am currently working on a Lead Validation Engineer (CSV / DeltaV) position. If you have relevant experience and are interested in this opportunity, please send me your updated resume.

Position: Lead Validation Engineer (CSV / DeltaV)
Location: Seattle, WA
Duration: Long Term

Job Overview

We are seeking a Lead Validation Engineer (CSV / DeltaV) to support a major biologics manufacturing operation in the Seattle area. The ideal candidate will have extensive experience in Computer System Validation (CSV), hands-on expertise with DeltaV systems, and a proven track record leading validation activities in GMP-regulated pharmaceutical or biotechnology environments. This role involves technical leadership, validation planning, protocol development, execution, and collaboration with cross-functional teams to ensure compliant system implementation and operation.

Key Responsibilities

• Lead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems.
• Develop and execute Validation Plans, Risk Assessments, Requirements Traceability Matrices (RTMs), IQ/OQ/IOQ Protocols, and Validation Summary Reports.
• Support DeltaV system implementations, upgrades, expansions, and modifications.
• Review and approve engineering documentation, functional specifications, design specifications, and configuration documents.
• Coordinate validation activities across Automation, Engineering, Manufacturing, IT, and Quality teams.
• Lead protocol execution, deviation investigations, issue resolution, and documentation closeout.
• Support change control activities and validation impact assessments.
• Provide technical guidance and mentorship to junior validation engineers.
• Drive risk-based validation and software assurance practices aligned with GAMP 5 and current industry standards.
• Support startup, commissioning, qualification, and operational readiness activities.
• Participate in project planning, scheduling, resource coordination, and stakeholder communications.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline.
• 8 years of Computer System Validation (CSV) experience within GMP-regulated pharmaceutical or biotechnology environments.
• Hands-on validation experience with DeltaV systems is required.
• Experience leading validation projects and coordinating cross-functional teams.
• Strong experience developing and executing Validation Plans, Risk Assessments, RTMs, IQ/OQ Protocols, and Validation Summary Reports.
• Strong knowledge of GAMP 5, CSA/CSV methodologies, 21 CFR Part 11, Data Integrity principles, and GMP documentation practices.
• Experience supporting biologics or pharmaceutical manufacturing facilities.
• Experience with DeltaV Batch, MES platforms, manufacturing automation systems, infrastructure qualification, and Commissioning & Qualification (C&Q) activities is highly desirable.
• Previous experience serving as a Validation Lead or Project Lead or working in a consulting environment is a plus.
• Excellent technical writing, communication, leadership, and client-facing skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Vakula Tech on LinkedIn for the latest job updates:
https://www.linkedin.com/company/vakula-tech

Thank you,

Sravani Dasari
Talent Acquisition Specialist
Vakula Tech Inc.
Email: jobs@vakulatech.com
Piscataway, New Jersey 08854
Website: www.vakulatech.com