Entry Level Commissioning & Qualification Engineer

PACIV • Indianapolis, IN • 1d ago

Entry-Level Commissioning & Qualification Engineer

PACIV stands for Process Automation, Controls, Instrumentation, and Validation.

At PACIV, we are passionate about delivering world-class automation & validation solutions that empower many industries and advanced manufacturing. Our teams thrive on innovation, collaboration, and solving complex challenges that shape the future of industrial automation.

Our Entry-Level Commissioning and Qualification Engineers play an important role in ensuring the integrity, reliability, and compliance of automated systems within a regulated environment. This position offers hands-on experience with commissioning, qualification, and related activities across a range of manufacturing systems.

This position requires direct employment. We do not consider C2C (Corp-to-Corp) or 1099 contract arrangements.

Job Responsibilities

Develop and drive completion of all Commissioning & Qualification (C&Q) deliverables; project validation plans, risk assessments, project strategies, user requirements, functional and design specifications, impact assessments, trace matrices, test cases/scripts, engineering studies, and final summary reports.

Apply a thorough understanding of commissioning and qualification processes to guide cross-functional teams and ensure adherence to all governing policies, procedures, and regulatory expectations.

Support the execution of large capital projects that expand pharmaceutical manufacturing capabilities; equipment for active pharmaceutical ingredient production, filling operations, device assembly, packaging, facilities, utilities, and automation systems.

Maintain and complete all client-required computer-based training to remain compliant with site and project standards.

Lead and participate in key project review meetings, including design reviews, alignment sessions, test strategy discussions, test execution reviews, project status updates, and qualification review boards.

Develop, review, and maintain documentation within an electronic lifecycle management system to support streamlined, paperless execution and traceability.

Ensure all change management activities are properly assessed and documented throughout the project, including updates resulting from design evolution, deviations, and testing failures.

Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to ensure equipment installation, configuration, and performance meet project and regulatory requirements.

Other duties as assigned

Qualifications

Bachelor's degree in engineering or related technical discipline required

Up to one (1) year of experience with C&Q deliverables, or relevant academic/project exposure

Required travel up to 40% domestically and/or internationally to support business operations

Expected to maintain a composed, solutions-focused mindset when navigating difficult or fast-paced situations

Highly motivated and results driven, with strong interpersonal, verbal, and presentation communication skills

Strong understanding of validation principles and deliverables, including requirements development, design, testing, and reporting

Demonstrated project management skills with the ability to lead tasks and drive projects to completion independently

Please Note: PACIV does not engage with external recruitment agencies. We kindly request that agencies do not contact us regarding this posting.

Compensation & Benefits Highlights

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 the monthly 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.

PACIV

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