Honeywell International - Pottsville, PA
posted about 2 months ago
Full-time - Mid Level
Pottsville, PA
Computer and Electronic Product Manufacturing
About the position
The Sr Advanced Quality Engineer at Honeywell will be part of a cross-functional team focused on process development, toller management, customer interaction, and regulatory compliance. This role is essential for driving quality improvements and ensuring adherence to customer and regulatory requirements throughout the production process.
Responsibilities
- Develop specifications for all SKUs
- Develop and validate test methods
- Specify testing and validation protocol for new SKUs
- Assess quality systems of potential tolling partners
- Develop toller quality management processes
- Monitor ongoing Cpks at tollers
- Lead continuous improvement efforts
- Conduct cost improvement analysis
- Drive technical solutions for quality improvements
- Assist/Lead projects to improve product quality
- Lead customer audits
- Work with customers and tollers to resolve customer complaints
- Generate certificate of analysis for customers
- Perform regulatory reviews
- Work with Product Stewardship for regulatory needs
- Perform risk analyses
- Perform analytical equipment maintenance and calibration
- Conduct FT-IR Validations
- Perform analytical testing including WVTR, Film Surface Energy, and Film Properties
Requirements
- Bachelor's degree in engineering
- Minimum 2 years working in cGMP environment
- Six Sigma certification
- Proficient computer skills
- Statistical analysis skills (Excel, Minitab, and other statistical tools)
Nice-to-haves
- Process Development skills and experience
- Experience with testing, validations, Customer CAPA process, Process Capability
- Compliance Knowledge in Pharma
- Proficiency in regulatory investigations
- Knowledge of pharma regulatory compliance guidelines, international regulation familiarity FDA, EMA, ANVISA, CFDA, Japan Ministry of Health
- Hands on work ethic
- Provide clear and concise communications
- Ability to work independently
- Ability to partner with others on projects
- Understanding of quality processes
- Film manufacturing experience
- Lead Quality Auditor skills
Benefits
- Employer subsidized Medical, Dental, Vision, and Life Insurance
- Short-Term and Long-Term Disability
- 401(k) match
- Flexible Spending Accounts
- Health Savings Accounts
- EAP
- Educational Assistance
- Parental Leave
- Paid Time Off (for vacation, personal business, sick time, and parental leave)
- 12 Paid Holidays
