Process/Validation Engineer
Process/Validation Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
- What are the top 3-5 skills experience or education required for this position.
- Process and Cleaning Validation Experience.
- Equipment Qualification (IOQ/PQ).
- Quality System Experience (Veeva Track wise Compliance Wire).
- Medical Device or Pharmaceutical Experience Required. Preferred Medical Device with 3-5 Years.
- Statistical Analysis (Minitab or JUMP).
- Implementing process and technology improvements.
- Process and Cleaning Validation.
- Equipment Qualification.
- Collecting monitoring analysing troubleshooting and reporting manufacturing data related to performance in the areas of quality cost and speed/service to market.
- Investigating non-conformances CAPAs process performance drifts and implementing corrective and preventative actions.
- Responsible for the initiation and follow-through of the change control processes.
- Bachelors degree in engineering science or closely related discipline is desired or equivalent technical experience plus demonstrated competence with a desired 3-5 years of significant process engineering and/or operational experience in Medical Device or Pharmaceutical industry. Additional post-graduate education may contribute towards the desired years of experience.
- Essential Skills Experience and Competencies (includes Licenses Credentials).
- Experience with MS Office applications including Word Excel & Outlook.
- Demonstrated understanding and use of statistical methods in experiment design and data analysis.
- Able to work independently and proactively in conjunction with all levels of the organization.
- Excellent Technical writing skills and attention to fine detail.
- Understanding of AATB FDA ISO ISPE and other regulatory guidelines including understanding of the various regulations and guidelines such as FDA 21 CFR 11 820 and 1270 ISO and 14644 and others as required.
- Six Sigma Value Stream Mapping Lean Manufacturing Design for Manufacturability DOE.
- Biological Products and aseptic processes.
- Development of robust manufacturing processes validation and process monitoring.
- Experience with root cause analysis methods.
- Experience with applications including Minitab or other statistical software Microsoft PowerPoint Project and Visio.
- Time management skills and follow-through skills with the ability to work on and manage multiple tasks with tight deadlines.
- Strategic thinking and planning.
- Excellent organizational skills.
- Excellent oral and written communication skills.
Employment Type
Full-time
