Location
Larwill, IN | United States
Job description
SUMMARY: The position of Validation Engineer is responsible for supporting our end of line operations (EOL) like cleaning, passivation, upgrade, and sterile packaging. He or she will drive a culture of continuous improvement in alignment with medical device regulations. The goal is to be the subject matter expert for end of line operations while supporting new validations, maintaining current validations, and improving processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES: ( includes the following but other duties may be assigned)
- Author and execute validation protocols and reports
- Review the quality, validation impact, and completeness of document change order requests and change controls for end of line processes
- Participate with cross-functional team to write PFMEAs.
- Perform process risk assessment for Non-Conformance Material Reports (NCMRs).
- Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects.
- Provide technical support (subject matter expert) during audits (internal and third-party audits).
- Assist in external audits for suppliers or third-party vendors.
- Propose, plan, and execute improvement projects.
- Develop/update departmental procedures and other controlled documents.
- Lead department and cross-department projects.
- Track and lead quarterly dose audit and revalidation activities.
- Assist in development, maintenance, and reporting of department metrics.
QUALIFICATION REQUIREMENTS:
- Associate Degree in Engineering or technical field
- 2+ years' experience in medical device equipment and process validations
- Green/Black belt, or Lean Sigma experience preferred
OTHER SKILLS and ABILITIES:
- Highly proficient in relationship building
- Expert in validation methods and evaluation criteria
- Cross-functional team experience
- Experience in one or more of the following: Cleaning Validation, Sterile Packaging, Sterilization Validation
BENEFITS:
- Competitive Paid Time Off
- Paid Holidays
- Group Medical Coverage
- Dental/Vision Coverage
- Short-Term and Long-Term Disability
- Referral Bonuses
- 401K Retirement Plan
Job tags
Salary
