Process Engineer II

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 technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products. We are proud to offer a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical device, specialty chemical and eChem industries. We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA's ChemStewards Management System. We believe the best scientific innovations are built through collaborations.

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.

What We Offer

Culture

Great people

Clean and Modern Equipment & Labs

Competitive Wages & Generous Year-end Bonus

3 PPO Medical Plans with Telemedicine, Rx, & Vision

401(k) with company match

Financial Health & Wellness w/1:1 Coaching & Rewards

Basic & Supplemental Life Insurance

Accident, Hospital Indemnity, & Critical Illness

Paid Time Off

Short & Long-term Disability

9 Paid Holidays

Must have legal authorization to work in the US and will not require sponsorship.

Polysciences is an equal opportunity employer. Drug-free workplace. Tobacco-free work site.

Polysciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need.

Equal access to programs, services, and employment is available to all persons. Those applicants requiring reasonable accommodation to the application process and/or interview process should notify a representative of the Human Resources Department.