- A minimum of 4-6 years of related experience.
- Must have Process Validation experience.
- Good technical understanding of manufacturing equipment and processes.
- Knowledge of statistical software packages (e.g. Minitab) with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
- Experience working in both an FDA and European regulatory environment in manufacturing/operations.
- A thorough understanding of GMP/ISO regulations and validation regulations
- The ability to perform 'hands on' troubleshooting and problem solving.
- Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook).
- In-depth knowledge of product/process Risk Management (FDA and ISO standards).
- Strong communication and interpersonal skills.
- Must have the ability to function in a team-based manufacturing environment.
- The ability to collaborate with all levels of management in a cross-functional team environment.
#4009
Job Types: Full-time, Part-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work setting:
Application Question(s):
Work Location: In person