PACIV · 1 day ago
Validation Engineer II
Indianapolis, IN
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expPACIV is a global leader in industrial automation, process control solutions, and instrumentation. They are seeking a detail-oriented and proactive Validation Engineer II to support compliance and efficiency in a regulated environment, responsible for managing periodic reviews of computer systems and collaborating on technical documentation.
Industrial AutomationManufacturing
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
Qualification
Required
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
Benefits
Generous Paid Time Off & 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
Company
PACIV
PACIV is an industrial automation company providing control panel fabrication services.
51-200 employees
H1B Sponsorship
PACIV has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (2)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
HCAP Partners
2023-07-05Private Equity
2023-06-05Acquired
Leadership Team
Rick Straw
Vice President of Operations / Partner
Erika Ariza
Global Talent Partner
Recent News
Private Equity News
2025-01-30
Company data provided by crunchbase