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Senior Quality Engineer
Senior Quality EngineerBEPC Inc. - Business Excellence Professional Consulting • Hillsboro, OR, US
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Senior Quality Engineer

Senior Quality Engineer

BEPC Inc. - Business Excellence Professional Consulting • Hillsboro, OR, US
17 days ago
Job type
  • Full-time
Job description

Job Description

BEPC is actively looking for Senior Quality Engineer in Hillsboro, OR area!

W2 Contract – 1 year with possible extensions!

Benefits include medical, dental, vision, and life insurance

Pay Rate : $54.74 - $64.74 / hour - Determined based on experience

Work Model : Onsite role

Note : This is a W2 only role — C2C, C2H will not be considered

BEPC is seeking a highly motivated Senior Quality Engineer to join our client’s site in Hillsboro, OR. This role will support a drug product and finished goods manufacturing organization responsible for the reliable delivery of commercial portfolio and pipeline products. The Operations organization consists of two operations that together produce millions of units of life-saving medicine every year for patients worldwide.

In this position, the selected individual will apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations, and industry standards to provide quality oversight for the site qualification / validation program.

Summary of Duties and Responsibilities :

  • Perform quality oversight of qualification and validation activities associated with equipment, facility and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods.
  • Provide guidance to internal customers on best practices for executing consistent, reproducible, and compliant qualification and validation activities.
  • Provide assessment and approval for changes that impact the validated state and / or require qualification / validation.
  • Review and approve documents supporting qualification and validation activities to ensure compliance with internal quality system requirements.
  • Provide input and quality oversight to qualification / validation exceptions and deviations.
  • Work on complex issues requiring in-depth evaluation of variable factors, including inter-organizational impact.
  • Exercise judgment based on analysis of multiple sources of information and collaboration with peers and cross-functional teams.

Qualifications :

  • Bachelor’s degree with 5–10 years of industry experience or equivalent qualifications.
  • Biopharmaceutical or pharmaceutical industry experience in technical validation or quality validation.
  • Strong technical knowledge of qualification and validation principles.
  • Ability to interpret and relate quality standards for implementation and review.
  • Ability to make sound decisions on quality and technical matters.
  • Sound knowledge of cGMPs or equivalent regulations.
  • Flexibility in problem solving and work hours to meet business objectives.
  • Ability to quickly and consistently establish rapport and collaborate effectively with team members and partners.
  • About BEPC

    BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

    Apply Now!

    Qualified candidates are encouraged to apply by submitting an up-to-date resume that highlights how your experience aligns with the role. Please include specific examples that demonstrate your qualifications. We look forward to connecting with you!

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    Senior Quality Engineer • Hillsboro, OR, US