Validation Engineer II

PACIV • Indianapolis, IN

48d • Onsite

About The Position

PACIV stands for Process Automation, Controls, Instrumentation, and Validation. As a global leader in industrial automation, process control solutions and instrumentation, we serve clients in the life sciences, pharmaceutical, medical device, food & beverage, and utilities sectors, specializing in delivering compliant, high-performance automation systems tailored to regulated environments. We are seeking a detail-oriented and proactive Validation Engineer II for our Indianapolis, IN office to support compliance and efficiency in a regulated environment. This role is responsible for executing and managing periodic reviews of computer systems, and driving resulting action items to completion.. The ideal candidate will collaborate cross-functionally to create, revise, and control technical documents, while also supporting system updates and process improvements.

Requirements

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Technical Writing, or Information Systems)
• Minimum 8 years proven experience in validation documentation within regulated environments (e.g., pharmaceutical, biotech, or life sciences).
• Strong understanding of Good Documentation Practices (GDP) and GMP compliance.
• Experience with TrackWise or similar quality management systems.
• Ability to collaborate with Subject Matter Experts to develop and revise technical documentation.
• Excellent attention to detail and organizational skills.
• Strong communication and stakeholder engagement abilities.

Responsibilities

• Execute Periodic Reviews of all departmental computerized systems supporting Clinical Trials (i.e. Parts Washers, Autoclaves, Filtration Systems, etc.)
• Create, track, and drive to completion action items for any deficiencies resulting from Periodic Reviews.
• Update Computer System Validation (CSV) documentation which may include design documents, local policies and procedures, tools, forms, and assessments.
• Support the development of reporting tools and methods to enhance visibility into periodic review progress and project metrics.
• Review validation documentation and ensure accuracy and compliance with local department and industry standards.
• Collaborate with cross-functional teams to ensure outputs of periodic reviews and any other CSV-related project deliverables meet local and regulatory requirements.

Benefits

• Generous Paid Time Off - Vacation, sick leave, and company-recognized holidays.
• Healthcare Coverage - PACIV covers 90% of your healthcare premium
• Health Savings Account (HSA) – Bi-monthly company contributions to cover out-of-pocket medical expenses.
• 401(k) Retirement Plan - Company match up to 4% & full vestiture on enrollment date

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees