Process Engineer II

About the role

The Process Engineer II at Polysciences supports commercial production and online troubleshooting for both the process and associated equipment. They collaborate with a cross-functional team to ensure improvements align with required design and development processes.

Responsibilities

• Support commercial production and online troubleshooting for both the process and associated equipment.
• Design, develop, implement and as needed, oversee systems to improve and sustain commercial manufacturing, cleaning, filling and packaging processes.
• Work collaboratively with a cross-functional team (R&D, Quality, QC, Production, EHS, etc.) to ensure improvements align with required design and development process.
• Author supporting process development documents such as SOPs, IOQs, Batch Records, Protocols and Reports.
• Aid in Nonconformance and OOS investigations to drive to root cause and implement effective CAPAs to mitigate repeat events.
• Lead a cross-functional team for implementation of new processes, systems, equipment, etc.
• Define, procure, install and qualify manufacturing equipment for commercial production.
• Lead continuous improvement projects for established products and systems.
• Represent projects technically for customer calls and meetings as projects progress through development.

Requirements

• Bachelor’s degree in Chemical Engineering
• Minimum of 2 years of engineering experience in a manufacturing environment or similar
• Familiarity with process scale-up, optimization, cleaning and validation activities preferred
• Knowledge of equipment specification, qualification and automation required
• Expertise with procurement and maintaining production equipment preferred
• LEAN / Six Sigma certification preferred

Qualifications

• Experience working in an ISO 13485 or FDA GMP environment preferred

Skills

• Lean / Six Sigma certification

Benefits

Polysciences offers a comprehensive benefits package including:

• 3 PPO Medical Plans with Telemedicine, Rx, & Vision
• 2 Dental Plans
• Healthcare, Dependent care, & Commuter
• Flexible Spending Accounts
• 401(k) with company match
• Financial Health & Wellness w/1:1 Coaching & Rewards
• Basic & Supplemental Life Insurance
• Tobacco-free work site
• Equal opportunity employer

Pay

Competitive wages and generous year-end bonus.

Schedule

Full-time position.