Engineer Process Support II

This is an onsite position 100% of the time.

The Process/Validation Engineer is responsible for providing engineering production support including:
Implementing process and technology improvements
Process and Cleaning Validation
Equipment Qualification
Collecting, monitoring, analyzing, 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.

Education and Experience

• Bachelor's 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 11737, 13485 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.

Preferred Skills

• 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.

What are the top 3-5 skills, experience or education required for this position:
1. Process and Cleaning Validation Experience
2. Equipment Qualification (IOQ/PQ)
3. Quality System Experience (Veeva, Trackwise, ComplianceWire)
4. Medical Device or Pharmaceutical Experience Required. Preferred Medical Device with 3-5 Years
5. Statistical Analysis (Minitab or JUMP)