Process Validation Engineer Life Sciences
Process Validation Engineer Life Sciences
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Salary Not Disclosed
1 Vacancy
Job Description
Job Duration: Long Term Contract (Possibility Of Further Extension)
Company Benefits: Medical Dental Vision Paid Sick leave 401K
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.
- Bachelors degree in Engineering Life Sciences or a related field.
- 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).
- Proficient in Microsoft Office Suite (Word and Excel) Google Workspace
- Experience with statistical analysis software (e.g. Minitab JMP) is preferred.
- Knowledge of Six Sigma or Lean methodologies is preferred.
Process, Validation, PQ, process qualification, GMP, ISO, life sciences
Education
Bachelor's degree
Employment Type
Full Time
