Validation Engineer (Level II)

Performance Validation; Indianapolis (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Performance Validation in Indianapolis, IN seeks an experienced Validation Engineer/Specialist (Level II) to lead the commissioning, qualification, and validation lifecycle across systems and equipment. You will craft testing criteria where protocols are absent, collaborate with clients and vendors, and mentor junior team members.

You will report to a Project Leader within a division that supports stock ownership and profit sharing in a 100% employee‑owned company.

Qualifications

• Bachelor’s degree or equivalent in a technical field; relevant Nuclear Navy training acceptable.

Responsibilities

• Apply a well-developed knowledge of pharmaceutical industry regulations and guidelines to client quality systems (CAPA, Change Control, Validation).
• Develop commissioning, qualification, and validation documents from planning and requirements through system acceptance and final summaries.
• Develop and deliver technical presentations to peers and clients.
• Implement end-to-end commissioning, qualification, and validation of systems or equipment.
• Independently develop testing criteria in new or undefined protocol contexts.
• Lead tasks and perform independent validation and commissioning work, mentoring junior staff.

Education

Bachelor’s degree in Engineering, Management, Life Sciences, or another related technical field — or equivalent Nuclear Navy training

Job description

Please see the links below for our current opportunities:

Certain positions at Performance Validation are designated as safety sensitive based on job duties and applicable law. Applicants for these roles may be subject to pre-employment drug testing, including for cannabinoids, where permitted by law.

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Location: Indianapolis, IN

Job Id:366

# of Openings:1

PERFORMANCE VALIDATION

About Us

Here at Performance Validation (PV) we have been providing Commissioning, Qualification, and Validation services to the life science industries for over 30 years! We are a 100% employee-owned company with teams in Indiana, Michigan, Illinois, Kansas, Washington, and North Carolina, and we support clients throughout the US and overseas. As an employer, PV is committed to providing growth opportunities to our employees through professional development, implementation of new services, and cultivation of new geographical areas.

About the Job

Performance Validation is seeking an experienced Validation Engineer/Specialist (Level II) to join our team in Indianapolis, IN. This is a role for someone who has moved past following existing protocols and is ready to build them — taking systems and equipment through the full commissioning, qualification, and validation lifecycle, from planning and requirements all the way to system acceptance and final summaries.

Much of the work happens where the answer is not written down yet. You will be trusted to think critically and develop testing criteria on your own when no relevant protocol exists, to propose and implement solutions as project work evolves, and to work directly with clients, vendors, management, and technical peers to reach consensus on design, testing, and approach.

It is also a step into leadership. Level II engineers lead tasks, perform independent validation and commissioning work, and mentor less experienced members of the team. You will be assigned to one or more project teams and report to a Project Leader, with your divisional home under a Division Director or Manager. At a 100% employee-owned company, the work you do here builds something you own a piece of due to stock ownership and biannual profit share.

What You Will Do

Knowledge

Apply a well -developed knowledge of pharmaceutical industry government regulations, industry standards, and guidelines.

Demonstrate an understanding of how those regulations and standards are incorporated into client quality systems — including CAPA, Change Control, and Validation.

Develop commissioning, qualification, and validation documents for a system or piece of equipment from beginning to end — planning and requirements through system acceptance and final summaries.

Develop and deliver technical presentations to peers and clients.

Development & Execution

Implement the commissioning, qualification, or validation of a system or equipment end to end.

Independently develop testing criteria in a creative environment where pre-existing protocol does not exist or is not relevant, written logically and clearly enough for others to follow.

Propose and implement solutions relating to project work.

Assess and develop the technical aspects of validation and commissioning activities — Master Plans, System Acceptance Final Reports, Risk Assessments, Audits, Gap Analyses, and Remediation Plans.

Assist in the development or improvement of client quality systems.

Develop and maintain equipment specification documents .

Work directly with clients, vendors, management, and technical peers to gain consensus on design, testing, and approach.

Leadership

Mentor less experienced resources.

Lead tasks and perform independent validation and commissioning work, applying good project practices throughout.

Requirements You Will Need

Education

Bachelor’s degree in Engineering , Management, Life Sciences, or another related technical field — or equivalent Nuclear Navy training.

Performance Validation is an Equal Opportunity Employer

We believe in the dignity, value, and potential of every individual. Performance Validation provides equal employment opportunities to all employees and applicants and makes employment decisions based on qualifications, merit, and business needs.

We do not discriminate on the basis of race, color, religion, creed, national origin, citizenship status, age, sex, pregnancy, sexual orientation, gender identity, marital status, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law. Performance Validation is committed to maintaining a workplace free from discrimination, harassment, and retaliation. We prohibit conduct that demeans, intimidates, threatens, or creates an offensive work environment based on any protected characteristic. Reasonable accommodations are available for qualified individuals with disabilities throughout the application and employment process.