Senior Validation Lead – CSV/OV for Pharma IT

NNE Inc.

Hinoba-an

On-site

PHP 995,000 - 1,393,000

Full time

11 days ago

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Job summary

NNE is seeking a Senior Quality Engineer – Computer System Validation to independently lead complex validation solutions across pharmaceutical manufacturing IT projects. You will provide quality leadership from requirements through testing, installation, handover, and close-out, balancing compliance risk, timelines, and usability.

Location: Bangalore, India. Experience: 6–8 years in CSV/QA within regulated industries.

Qualifications

Bachelor’s or master’s degree in engineering, computer science, life sciences, pharmacy or related discipline.
Minimum 6–8 years in CSV, OV, qualification or QA within regulated industries.
Proven experience in leading validation and quality review activities per regulatory expectations.
Strong knowledge of GMP, 21 CFR Part 11 and data integrity principles.

Responsibilities

Lead CSV/OV strategy, validation planning, and execution activities.
Guide teams in protocol, test plan, and validation deliverable preparation and execution.
Support FAT, SAT, UAT, IQ/OQ/PQ, defect management, deviation handling, and TIMS activities.
Ensure compliance with GMP, GEP, GAMP 5 and regulatory requirements across projects.
Conduct and participate in risk assessments and quality reviews.
Review requirements, design specs, test docs, and validation reports.
Coordinate validation activities across IT, OT, Automation, Engineering and Quality teams.
Oversee supplier deliverables, including SIR/SIP reviews where needed.
Support project planning, estimation, progress tracking, issue resolution and customer interactions.
Drive continuous improvement initiatives and department process development.
Support SER/SAR preparation and ensure successful project handover and closeout.