Process Engineer II: GMP Manufacturing & Optimization

Polysciences, Inc.; Warrington Township (Bucks County); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Competitive wages

Year-end bonus

Health insurance plans

401(k) with company match

Paid time off

Disability coverage

Holidays

Job summary

Polysciences, Inc. is seeking a Process Engineer II to optimize and monitor manufacturing processes. You will collaborate with R&D and multiple departments to transfer early-stage products to production and implement improvements for efficiency.

You will design, qualify and oversee systems, participate in CAPA investigations, and lead cross-functional teams to deploy new processes and equipment on a commercial scale.

Qualifications

• Bachelor's degree in Chemical Engineering required.
• Experience in ISO 13485 or FDA GMP environments preferred.
• A minimum of 2 years of engineering experience in manufacturing.
• Familiarity with process scale-up, cleaning and validation activities.
• Knowledge of equipment specification, qualification and automation.
• Experience procuring and maintaining production equipment.

Responsibilities

• Support production and online troubleshooting for process/equipment.
• Design and implement systems to improve manufacturing, cleaning, filling and packaging.
• Collaborate with R&D, Quality, QC, Production, EHS on improvements.
• Author SOPs, IOQs, Batch Records, Protocols and Reports.
• Assist in nonconformance and OOS investigations and drive CAPAs.
• Lead cross-functional teams for new processes, systems or equipment.
• Define, procure, install and qualify manufacturing equipment.
• Lead continuous improvement projects for established products.
• Represent projects technically for customer calls and progress reviews.

Skills

Process optimization

Cross-functional collaboration

Troubleshooting

Project leadership

Automation knowledge

Education

Bachelor's degree in Chemical Engineering

Tools

Equipment qualification processes

Procurement of production equipment

Job description

Polysciences, Inc. is seeking a Process Engineer II to optimize and monitor manufacturing processes. You will collaborate with R&D and multiple departments to transfer early-stage products to production and implement improvements for efficiency.

You will design, qualify and oversee systems, participate in CAPA investigations, and lead cross-functional teams to deploy new processes and equipment on a commercial scale.