Principal Validation Engineer - CSV Program Lead

As a Principal Validation Engineer - CSV Program Lead, you’ll drive transformative compliance and validation projects, establishing technical vision and strategy to enhance efficiency, regulatory compliance, and operational excellence. This role offers a unique opportunity to collaborate with industry leaders, shaping advanced validation solutions within the pharmaceutical sector. At PACIV, you’ll be part of a collaborative environment that fosters continuous learning, career growth, and the freedom to innovate in an industry that’s redefining the future of manufacturing and compliance standards.

If you’re ready to step into a leadership role in computer systems validation and drive impactful change, the Principal Validation Engineer - CSV Program Lead position at PACIV is where your expertise meets the opportunity. Join us and make your mark on an industry-leading team dedicated to innovation and excellence!

About PACIV: We are a global leader in control systems integration and regulatory compliance engineering. For over two decades, we’ve been at the forefront of innovation and operational excellence for clients in Biopharma, Life Sciences, Medical Devices, Food & Beverage, and Water/Wastewater industries. Check out our website: www.paciv.com and social media for more information.

Location: On-site

About the Role: PACIV is seeking an experienced Principal Validation Engineer - CSV Program Lead to set up and oversee CSV (Computer System Validation) deliverables for a high-impact automation program. This role requires a seasoned validation professional ready to lead efforts across quality assurance, planning, documentation, and compliance, ensuring alignment with corporate and regulatory standards. As the CSV Program Lead, you will interface with key stakeholders, maintain validation rigor, and ensure high-quality deliverables that support operational excellence and validated systems within the pharmaceutical environment.

Key Responsibilities:

• Stakeholder Collaboration: Interface with Subject Matter Experts, Site Management, Quality Assurance, and client resources to gather essential information for validation project planning.
• Documentation & Compliance: Draft and maintain program CSV deliverables, including Validation Plans, Security Plans, and Test Plans. Ensure that all documentation adheres to corporate quality standards, practices, and document management guidelines.
• Validation Execution: Support individual project validation documentation (e.g., Validation Plans, Test Plans, and Electronic Testing Templates). Educate and troubleshoot as needed to ensure quality in executed test cases.
• Process Improvement: Proactively recommend improvements to enhance consistency and compliance across CSV deliverables.
• Project Tracking & Reporting: Create customized reports, views, and queries in Change Management, Electronic Document Management, and Electronic Test systems to facilitate project tracking.
• Mentorship & Training: Provide CSV guidance and mentoring for automation teams, other functional SMEs, and team members. Support onboarding, training, and other personnel-related needs.
• Relationship Building: Cultivate strong relationships with CSQA personnel, maintaining awareness of corporate quality expectations and ensuring timely responses to changes.
• Future Planning: Anticipate validation needs and trends to ensure ongoing compliance and validated system states for customer systems.

Education and Skills:

• Education: A bachelor’s degree in engineering or equivalent experience is preferred.
• Experience: 10+ years of experience in CSV within the pharmaceutical industry, with expertise in large-scale pharmaceutical automation projects.
• Technical Skills: Familiarity with Electronic Document Management and Electronic Test Management systems is preferred, alongside strong Microsoft Office skills, attention to detail, and proficiency in managing multiple projects simultaneously.
• Communication & Reporting: Excellent communication skills with experience in web-based applications and reporting tools, particularly in change management and document management systems.
• Team Collaboration: Exceptional teamwork skills and the ability to collaborate effectively with cross-functional teams.

Position Location: Lebanon, Indiana Travel: Up to 20% of the time to various suppliers, collaborators, and client sites outside of Indianapolis

Compensation:

Competitive Salary and Benefits Package, which includes:

• Paid Time Off (PTO) for vacation, sick, and company holidays.
• PTO is earned on an accrual basis throughout the calendar year.
• Health Insurance:  PACIV pays 90% of the premium for the health insurance plan. Monthly contributions are made by PACIV and are distributed through an HSA (Health Savings Account).
• $25,000 Basic Life Insurance Plan for all full-time employees, with additional plan options offered at the employee’s cost.
• 401(k) Retirement Plan with company match.
• Project Performance Bonuses (for qualified projects and employees).

PACIV provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.