Website eTeam Inc.
eTeam Inc.
Company : eTeam Inc.
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.
ET_HRHC01