Validation Engineer

Performance Validation
  • Raleigh, North Carolina
    30+ days ago

    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 37 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 2 Validation Engineer/Specialist to join our team in Raleigh, NC The Level II 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 and 1-2 years in pharmaceutical or other regulated industry experience directly related to pharmaceutical validation
    • BS degrees in Biomedical Engineering, Chemical Engineering or Mechanical Engineering preferred

    Experience:
    • Change and Deviation Management
    • Strong interpersonal skills.  Must interact confidently with clients, other contractors, and employees
    • Possess excellent oral and written communication skills and high attention to detail
    • Cleaning, Sterlization, and Decontamination Validation experienced preferred
    • Device Assembly and Packing experience preferred

    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 harmony

    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.

    Numbers & Facts

    LocationRaleigh, North Carolina
    Websitehttps://perfval.com/join-pv/pv-careers/

    Skills

    • Biologyunmatched
    • Biomedical Engineeringunmatched
    • Biotech and Pharmaceuticalunmatched
    • Change Controlunmatched
    • Change Managementunmatched
    • Chemical Engineeringunmatched
    • Commissioningunmatched
    • Communication Skillsunmatched
    • Customer Relationsunmatched
    • Customer Support/Serviceunmatched
    • Detail Orientedunmatched
    • Functional Requirements Document (FRD)unmatched
    • Interpersonal Skillsunmatched
    • Mechanical Engineeringunmatched
    • Multitaskingunmatched
    • Presentation/Verbal Skillsunmatched
    • Process Validationunmatched
    • Requirements Managementunmatched
    • Team Buildingunmatched
    • Team Playerunmatched
    • Technical/Engineering Designunmatched
    • Test Designunmatched
    • Willing to Travelunmatched
    • Writing Skillsunmatched

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