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The future is what you make it.

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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

• Minimum 2 years working in cGMP environment

• Six Sigma certification

• Proficient computer skills

• Statistical analysis skills (Excel, Minitab, and other statistical tools)

WE VALUE

• 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.