Lead Automation Validation Engineer

Lead Automation Validation Engineer provides technical leadership for validation execution, mentoring engineers and ensuring high-quality protocol development and testing. Executes validation activities for complex automation systems.

• Lead development of validation strategies, protocols, and reports (IQ/OQ/PQ).

• Project-level validation owner.

• Partner with Engineering, Manufacturing, and Software teams to ensure seamless project delivery.

• Apply standards and templates to project execution.

• Approves project validation deliverables and Summary Reports.

• Guide Validation Engineers in test execution and deviation management.

• Support hardware/software integration and end-to-end system qualification.

• Collaborate with project teams to resolve technical validation challenges.

• Collaborate with controls and software engineering to develop the User Acceptance Testing Plan during the engineering phase.

• Collaborate with controls and electrical engineering to develop the controls DOO for complex automation systems.

• Execute end-to-end system OQ and PQ testing at project sites for complex automation systems.

• Prepares Validation Summary Reports and manages defect resolution through completion.

• Hours are calculated based on 25-30% of overall project hours spent in office and 70-75% of overall project hours spent in the field. Hours in the field will be spent with 10 days on the job site and 4 days off at home. A typical two weeks of ‘field time’ will look like this:

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 While performing the duties of this job, the associate will be required to work in areas that are not environmentally controlled, possibly very hot or cold conditions. Some areas may have exposure to contaminant and the noise level in the work environment is usually moderate. There will also be some walking, standing, bending, occasional carrying of medium to heavy items, etc.

 Additional work atmosphere considerations are work on a ladder, mezzanine, or scissor lift etc. May work in cramped areas or involve awkward positions; may climb over and around material and equipment. Associate(s) may be required to wear personal protective equipment in accordance with regulatory agencies.

Requirements

• Bachelor’s degree in engineering or related discipline.

• 7+ years validation engineering experience with protocol authorship.

• Demonstrated leadership in regulated commissioning/qualification projects.

• Proficiency in PLCs, Java, Python, or C++

• Experience with automation tools and frameworks.

• Proficiency in navigating AutoCAD, SolidWorks, and Navisworks.

Preferred Qualifications:

• Experience leading validation for automated systems.

• Mentoring or team lead experience.

Core Competencies:

• Technical leadership

• Protocol expertise

• Analytical thinking

• Coaching

• Quality mindset

• Must possess strong communications skills with an ability to communicate directly with technical team members and executive management team.

• Must possess the ability to manage multiple timelines and complete tasks quickly within the constraints of timelines and budgets.

• Must possess the ability to work effectively as an individual and part of a senior team.

• This position supervises teams of 4-6 and is responsible for providing input to the Senior Manager of the department of performance management and hiring of the employees within that department.

Benefits

• Medical Insurance

• Dental Insurance

• Vision Insurance

• Health Care Concierge Service

• 401(k) Retirement Plan (Pre-tax & Roth)

• Company paid Basic Life Insurance, Short-Term Disability & Long-Term Disability

• Voluntary Life & AD&D Insurance

• Voluntary Accident, Critical Illness & Hospital Indemnity Insurance

• Pet Insurance

• Milk Stork Program

• Wellness Program with gift card redemption and wellness challenges

• Paid Time Off (Vacation, Sick & 10 Holidays)

• Training & Development
  KPI Solutions provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by states, federal, or local law.