On site in Tucson
This is in the Engineering category
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.
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.
This is the pay range that Magnit reasonably expects to pay for this position: $30.00/hour-$37.00/hour
Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met)
Magnit has an ongoing commitment to the diversity and inclusion of all team members. We believe that embracing diversity leads to innovation and helps address the needs of the business. We welcome individuals from different backgrounds, experiences, and cultures to join our team. We value this diversity and strive to create an inclusive environment that celebrates these unique perspectives, allowing you to contribute to your full potential. Finally, but most importantly, we expect all team members to be treated with dignity and respect.
If you have a disability and need an accommodation in relation to the online application process, please email us at Roche.Accommodations@magnitglobal.com