Job Information
Honeywell Sr Advanced Quality Engineer with Relocation in Pottsville, Pennsylvania
The future is what you make it.
When you join Honeywell, you become a member of our global team of thinkers, innovators, dreamers and doers who make the things that make the future. That means changing the way we fly, fueling jets in an eco-friendly way, keeping buildings smart and safe and even making it possible to breathe on Mars. Working at Honeywell isn’t just about developing cool things. That’s why all of our employees enjoy access to dynamic career opportunities across
Be a part of a cross-functional team working with process development, toller management, customer interaction, and regulatory requirement at the Pottsville, PA site. This role will apply expertise and knowledge in finding innovative, cost-effective means to improve quality output and continuous improvements. You will drive process initiatives that ensures compliance with customer requirements, regulatory agencies, government regulations and engineering specifications while instilling accountability for governance of the Quality System, product acceptance and, product quality from development through day-to-day production.
Key Responsibilities
Process Development
Develop specifications for all SKUs
Develop and validate test methods
Specify testing and validation protocol for new SKUs
Toller Management
Assess quality systems of potential tolling partners
Develop toller quality management processes
Monitor ongoing Cpks at tollers
Lead continuous improvement efforts
Cost improvement analysis
Drive technical solutions for quality improvements
Customer Interaction
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
Regulatory
Perform regulatory reviews
Work with Product Stewardship for regulatory needs
Perform risk analyses
Analytical Equipment service and calibration
Perform analytical equipment maintenance and calibration
FT-IR Validations
Analytical Balances
Agilent GC CTFE standards
Minolta Meter
Die Line Camera
WaveScan Dual
HazeGard
ZST timers and temperature checks
Oven temperature checks
Pycnometers
Emveco micrometer
Tape Rules
Steel Rules
Analytical Testing
WVTR
Film Surface Energy
Film Properties
U.S. PERSON REQUIREMENTS
Due to compliance with U.S. export control laws and regulations, candidate must be a U.S. Person, which is defined as, a U.S. citizen, a U.S. permanent resident, or have protected status in the U.S. under asylum or refugee status.
YOU MUST HAVE
Bachelors Degree in Engineering
Proficient computer skills
Statistical analysis skills (Excel, Minitab, and other statistical tools)
WE VALUE
Minimum 2 years working in cGMP environment
Six Sigma certification
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
Ability to travel 25% of time, both domestic and international
Understanding of quality processes
Film manufacturing experience
Lead Quality Auditor skills
Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.
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