Validation Engineer II
1 day ago
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.
This position requires direct employment.
We do not consider C2C (Corp-to-Corp) or 1099 contract arrangements.
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.
- 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.
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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