Senior Validation Project Lead

PACIV • Indianapolis, IN

32d

About The Position

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.

Join our Indianapolis, IN team as a Senior Validation Project Lead and take ownership of validation initiatives for major capital projects. This position will lead a talented engineering team, develop and execute essential C&Q deliverables, ensure compliance with industry regulations, work closely with cross-functional partners to deliver innovative and robust solutions.
This position requires direct employment.
We do not consider C2C (Corp-to-Corp) or 1099 contract arrangements.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline.
• Minimum 8 years of validation engineering leadership experience, with expertise in executing core validation deliverables such as requirements documentation, design specifications, testing protocols, and final reports.
• Proficient 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.
• Proven ability to lead and drive projects independently, utilizing project management skills to coordinate cross-functional teams and meet critical deadlines.
• Collaborative team player with a strong sense of ownership and accountability.
• Excellent interpersonal and communication skills, verbal, written, and presentation abilities.
• Willingness to travel to support project needs at supplier locations, partner sites, and client facilities.

Responsibilities

• Serve as a custodian of the Commissioning and Qualification (C&Q) process by adhering to defined policy and procedure, defined workflows. Influence without authority the process implementation among cross-functional project teams.
• Develop, manage, and execute project C&Q strategies that align with defined risks, project delivery timelines, and overarching policies and procedures.
• Lead and participate in Design Reviews with cross functional teams in including equipment manufacturers to establish action items and assess impacts to C&Q aspects.
• Drive completion of the planning phase of asset delivery projects by writing project validation plans and driving successful completion of requirements documentation.
• Collaborate with equipment manufacturers, process engineers, and automation engineers to develop testing documentation, component level risk assessments, and testing strategies.
• Oversee and participate in FAT/SAT execution
• Own the in-project change control process ensuring changes to the project are clearly documented and resolved.
• Establish accountability with project teams, updating documentation, restricting tests of unapproved changes, coordinating tests and retests as needed
• Prepare qualification reports and lead qualification review meetings to ensure the executed qualification process meets the defined plan and project requirements. Document and drive resolution any deficiencies.
• Guide teams through the C&Q process to ensure readiness for Performance Qualification (PQ).
• Promote digital execution using electronic lifecycle management systems (e.g., Kneat Gx).
• Lead C&Q activities for large-scale pharmaceutical capital projects, ensuring alignment with client goals, regulatory standards, and timelines.
• Manage and mentor multidisciplinary engineering teams to foster collaboration and high performance.
• Serve as the primary liaison between internal teams and external stakeholders to ensure clear communication and issue resolution.
• Build and manage C&Q staffing models; support recruitment and resource planning aligned with project scope and budget.
• Monitor project scope, schedules, and budgets; provide regular updates to leadership and clients.

Benefits

• Generous Paid Time Off & Company-Recognized Holidays
• Healthcare Coverage - PACIV covers 90% of the healthcare premium
• Health Savings Account (HSA) – Bi-monthly company contributions to help out-of-pocket medical expenses.
• 401(k) Retirement Plan - Company match up to 4% & full vestiture on enrollment date

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 101-250 employees