Validation Engineer

Validation Engineer – Indianapolis, IN

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 Validation Engineer to join our team onsite in Indianapolis, Indiana, supporting a biotechnology and pharmaceutical client. In this role, manages key aspects of commissioning, qualification, and validation activities across regulated manufacturing environments. As part of PACIV’s Outsourcing Services Provider (OSP) model, working closely with the client’s validation, project management, quality, and automation teams to ensure compliance and operational excellence.

Job Responsibilities

• Lead the development and successful completion of key Commissioning and Qualification (C&Q) deliverables, project validation plans, risk assessments, strategic documentation, user requirements, functional and design specifications, impact assessments, traceability matrices, test protocols, engineering evaluations, and final summary reports.
• Demonstrate deep expertise in the C&Q process, guiding cross-functional teams to ensure strict compliance with established policies and procedures.
• Oversee change management throughout the project lifecycle, ensuring all modifications whether due to design evolution or test execution outcomes are properly assessed and documented.
• Facilitate and actively contribute to critical project meetings, design reviews, alignment sessions, test strategy discussions, execution reviews, project status updates, and qualification assessments.
• Monitor and report on project scope and budget implications pertaining to Commissioning and Qualification activities, ensuring alignment with project goals.
• Create and maintain comprehensive documentation within an electronic lifecycle management system, enabling efficient and paperless execution.
• Support the implementation of large-scale capital projects expanding pharmaceutical manufacturing capabilities, equipment and systems for API production, filling operations, device assembly, packaging, facility infrastructure, utilities, and automation.

• Bachelor’s degree in Engineering or a related technical discipline is required
• Minimum 3 years of validation experience in the pharmaceutical industry, with hands-on familiarity in executing core validation deliverables; requirements, design documentation, testing protocols, and final reports.
• Experienced in Commissioning & Qualification (C&Q) and/or Computer System Validation (CSV), with a solid understanding of Data Integrity principles and compliance with 21 CFR Part 11 regarding electronic records and signatures.
• Comfortable working in a 24/7 manufacturing environment, adaptability and resilience in fast-paced, high-pressure setting
• Proven ability to lead and drive projects to completion independently, leveraging project management skills to coordinate cross-functional teams and meet critical deadlines.
• Collaborative team player, consistently contributing to team success while maintaining ownership of individual responsibilities.
• Self-motivated and results-driven, with a proactive approach to problem-solving
• Strong interpersonal and communication skills, including effective verbal, written, and presentation abilities that support clear collaboration across teams and stakeholders.
• Willingness to travel up to 40%, supporting project needs at supplier locations, partner sites, and client facilities

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.