Senior Validation Engineer – Project Lead

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 Senior Validation Engineer – Project Lead for our Indianapolis, IN office, to direct and support validation efforts across large-scale capital projects in pharmaceutical manufacturing. This role involves driving the development and execution of key C&Q deliverables, ensuring compliance with regulatory standards, collaborating with cross-functional teams to implement robust systems and processes.

Technical 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).

Project Management Responsibilities

• 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.

Qualifications

• 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 up to 40% to support project needs at supplier locations, partner sites, and client facilities.

Compensation & Benefits Highlights
PACIV offers a competitive salary with comprehensive benefit package designed to support the well-being and financial future of our employees

• Generous Paid Time Off - Includes vacation, sick leave, and 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
• Performance-Based Bonuses - Eligible employees may receive bonuses tied to project success and individual contributions.

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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