Validation Specialist II

Job Description

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 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.

Job 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.

Qualifications

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

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.