The Process Engineer II is responsible for optimizing and monitoring processes and systems. The Process Engineer II works with the R&D team to transfer early stage products into the production area to create the commercial process. They are responsible for implementing improved processes for more efficient production. They are also responsible for system design, implementation and oversite to facilitate and sustain process improvements.

Essential Functions:

• 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.
• Assist 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.

Qualifications:

• Bachelor’s degree in Chemical Engineering
• Experience working in an ISO 13485 or FDA GMP environment preferred.
• A minimum of 2 years of engineering experience in a manufacturing environment or similar required.
• 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

Education Required: Bachelor's Degree Preferred: Bachelor's Degree

Certification(s): Specify preferred or required.

Computer Skills Required: Specify preferred or required.

Proficiency with Microsoft Word and Excel required.

Experience with statistical software such as Minitab, JMP or Stat-Ease preferred.

Familiarity with SAP or similar ERP system and Blue Mountain or similar CMMS preferred.

Other qualifications:

• Bachelor’s degree in Engineering, chemical, industrial or mechanical preferred.
• Experience working in an ISO 13485 or FDA GMP environment preferred.
• A minimum of 2 years of engineering experience in a manufacturing environment or similar required.
• 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.

Immediate Work Environment:

X- Chemicals Unprotected Height Fumes/Gases Persistent Noise

X- PPE used: Lab Coat, Safety Shoes, Safety Glasses.

Work Activity: [must equal number of hours worked per day]

Stand: 3 Frequency: Intermittently Walk: 1 Frequency: Intermittently

Sit: 4 Frequency: Intermittently Drive: 0 Frequency: Choose an item.

Lift/Carry Demands

Frequency: Lift/Carry Equipment Provided:

0-10 lbs. Less than 1 hour a day Supporting equipment – tools, spare parts, etc.

11-25 lbs. Not Daily Supporting equipment – hoses, lids, mixer props, etc.

26-50 lbs. Not Daily Carts, Wheeled Reactors, Pallet Jacks of materials, etc.

51-75 lbs. Never

76-100 lbs. Never