Validation Specialist

Salary :

$80,000 - 85,000 yearly

Company : Paciv

Job Type : Full Time

Indianapolis, In

Number of Applicants

000+

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Job Description - Validation Specialist

PACIV is a global leader in industrial automation and process control solutions, serving 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 Specialist 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.

Job Responsibilities

Execute periodic reviews of all departmental computer systems.
Create, revise, and manage Computer Validation System (CSV) documentation to support validation execution and regulatory compliance.
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 procedures, tools, forms, and assessments.
Review validation documentation and ensure accuracy and compliance with local department and industry standards.
Provide technical support for validation activities, including documentation systems and process improvements.
Collaborate with cross-functional teams to ensure outputs of periodic reviews meet project and regulatory requirements.
Support the development of reporting tools and methods to enhance visibility into periodic review progress and project metrics.

Qualifications

Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Technical Writing, or Information Systems) preferred.
Minimum 3 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.

Compensation & Benefits Highlights
PACIV offers a competitive salary with a comprehensive benefits package designed to support the well-being and financial future of our employees

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

PACIV is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.
PACIV complies with all applicable federal, state, and local laws regarding non-discrimination and affirmative action. Employment is contingent upon successful completion of background checks and eligibility to work in the United States.

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Validation Specialist

Job Description - Validation Specialist

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