Staff Validation Engineer

P

PerfVal Labs, Inc.

Posted 3 months ago

Full Time

Concord, North Carolina

In Person

Smart Summary

Responsibilities

The Validation Engineer will develop and execute qualification deliverables such as IQ/OQ/PQ protocols and summary reports. They will also manage change control activities and resolve non-conformances while working within project teams.

Qualifications

Performance Validation is seeking a Level I Validation Engineer/Specialist with a BS/BA degree or three years of experience in a regulated industry. Key requirements include strong interpersonal and communication skills, experience with Microsoft Office, and the ability to work independently. A degree in Biomedical, Chemical, or Mechanical Engineering is preferred.

Job Description

About Us
Here at Performance Validation, Inc (PV) we have been providing Commissioning, Qualification, and Validation services to the life science industries for over 36 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 a full-time Level I Validation Engineer/Specialist to join our team in Kenosha Wisconsin. Level I Validation Engineer/Specialist reports directly to the Site Manager and will be assigned to one or more project teams headed by a Project Leader.

Responsibilities
  • Develop a sound understanding of how to properly implement technical, quality, and scientific principals necessary to meet industry and customer requirements
  • Work in a team environment to meet defined objectives based on established timelines
  • Develop verification/qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports
  • Execute test protocols, including identification and resolution of non-conformances/deviations
  • Track and manage change control activities for multiple concurrent projects


Requirements you will need

Education:
  • BS/BA degree or three years in pharmaceutical or other regulated industry experience not directly related to pharmaceutical validation
  • BS degrees in Biomedical Engineering, Chemical Engineering or Mechanical Engineering preferred
Experience:
  • Self-starter who exhibits a professional demeanor, enthusiasm, and ability to work independently with minimal supervision
  • Strong interpersonal skills.  Must interact confidently with clients, other contractors, and employees
  • Possess excellent oral and written communication skills and high attention to detail
  • Experience with office word-processing and spreadsheet programs such as Microsoft Word and Excel

What we have to offer
  • Competitive base salary
  • Biannual profit share
  • Employee stock ownership program
  • 401(k) company match
  • Flexible Time Off Policy
  • Paid Parental Leave
  • Internal and external training opportunities
  • Medical, vision, and dental coverage
  • Disability and life insurance
  • Cellphone stipend
  • Growth opportunities
  • Company-sponsored team building outings
  • A collaborative work environment
  • Work/life balance

This role involves frequent travel to client and partner sites, estimated at 30–50% depending on business needs and project cycles.

Qualified candidates must be legally authorized to be employed in the United States. Performance Validation, Inc. does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

P

PerfVal Labs, Inc.

Performance Validation (PV) is a global validation partner for pharmaceutical and medical device manufacturers. Headquartered in Indianapolis, IN, we specialize in turning compressed timelines into compliant ones using innovative, adaptive approaches that balance production realities with strict regulatory requirements. Our best-in-class, cGMP-compliant services cover diverse needs from fully managed CQV to on-demand temperature mapping, smoke studies, software assurance, and more. With a dedicated team consisting of more than 95% engineers, we work closely with regulators and equipment suppliers to keep validation ahead of production curves and keep quality moving forward.
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