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Process Validation Engineer

Oro Valley, AZ 85755

Posted: 05/02/2025 Employment Type: Contract Industry: Other Job Number: 12131 Pay Rate: $19.00 - $37.00 Remote Friendly: Onsite

Job Description

Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.


Overview:
  • We are seeking a highly motivated and detail-oriented Process Validation Engineer with 1-3 years of experience to join our team.
  • The Process Validation Engineer will be responsible for developing and executing process validation and/or process verification protocols and reports to ensure that manufacturing processes are compliant with regulatory requirements and company standards.
  • This role involves collaborating with cross-functional teams to support continuous improvement and maintenance of validated processes.

Responsibilities:
  • Develop, write, review, and execute process validation/process verification protocols and reports.
  • Conduct risk assessments and develop validation strategies for new and existing processes.
  • Analyze and interpret process validation data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
  • Collaborate with Manufacturing, Quality, Design Transfer Operations, and other
  • departments to resolve validation issues and implement corrective actions.
  • Participate in process optimization and continuous improvement initiatives to enhance quality and efficiency.
  • Ensure compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements.
  • Provide training and guidance to manufacturing and quality personnel on validation processes and procedures.
  • Maintain process validation documentation and ensure traceability and accessibility for audits and inspections.
  • Other duties as assigned by management.

Job Requirements

Qualifications:
  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • 1-3 years of experience in process validation within a regulated industry (pharmaceutical, medical device, biotechnology, etc.).
  • Strong understanding of process validation principles, techniques, and industry standards.
  • Familiarity with regulatory requirements (FDA, ISO) and Good Manufacturing Practices (GMP).
  • Excellent analytical, problem-solving, and critical-thinking skills.
  • Strong written and verbal communication skills.
  • Ability to work both independently and as part of a multidisciplinary team.
  • Detail-oriented with strong organizational and time-management skills.
  • Proficient in Microsoft Office Suite (Word and Excel), Google Workspace.

Preferred Qualifications:
  • Experience with statistical analysis software (e.g., Minitab, JMP).
  • Previous experience in a cleanroom or controlled environment.
  • Knowledge of Six Sigma or Lean methodologies.

Meet Your Recruiter

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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About Oro Valley, AZ

Ready to take the next step in your career? Explore our job opportunities in the vibrant city of Oro Valley, Arizona! Nestled in the picturesque Sonoran Desert, Oro Valley offers a perfect blend of breathtaking natural beauty, a thriving job market, and a welcoming community. With its proximity to the stunning Catalina State Park for outdoor enthusiasts, renowned art galleries like the Etherton Gallery in nearby Tucson, and a vibrant culinary scene boasting local favorites like Sonoran hot dogs, Oro Valley is a hub of endless possibilities. Join us in this dynamic region, where growth opportunities abound and a unique blend of culture and charm awaits you. Discover your next career move in Oro Valley today!