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Process Validation Engineer, onsite | 1024107
Tucson, AZ
Ventana
Contract
$1 USD/Year
Posted 05/22/2025
Job Description
OUR GOAL:
Treat our consultants and clients the way we would like others to treat us!
Interested in joining our team? Check out the opportunity below and apply today!
We are seeking a highly motivated and detail-oriented Process Validation Engineer with 1-3 years of experience to join the team in Tucson, AZ. 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.
Reference: 1024107
Revel IT is an Equal Opportunity Employer. Revel IT does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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Job ID:
405837
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