Process Engineer II

Polysciences, Inc.; Warrington Township, Northern (Bucks County, KY); Hybrid; USD 100,000 - 125,000; Full time

Benefits offered by this job

Competitive wages

Year-end bonus

Comprehensive benefits

401(k) with company match

Job summary

Polysciences, Inc. in Warrington, PA is seeking a Process Engineer II to optimize and monitor manufacturing processes and transfer early-stage products to production.

You will work with R&D and cross-functional teams to implement efficient processes, design and qualify equipment, and lead continuous improvement projects.

Qualifications

• Bachelor’s degree in Chemical Engineering is required.
• Experience in ISO 13485 or FDA GMP environments preferred.
• At least 2 years of engineering experience in manufacturing.
• Familiarity with process scale-up, cleaning and validation activities.
• Knowledge of equipment specification, qualification and automation is preferred.
• LEAN / Six Sigma certification preferred.

Responsibilities

• Support commercial production and online troubleshooting for the process and equipment.
• Design, develop and implement systems to improve manufacturing processes.
• Collaborate with R&D, Quality, QC, Production and EHS to align improvements.
• Prepare SOPs, IOQs, Batch Records, Protocols and Reports.

Skills

ISO 13485 experience

FDA GMP experience

LEAN / Six Sigma

Process scale-up

Automation knowledge

Education

Bachelor’s degree in Chemical Engineering

Tools

SAP

CMMS (Blue Mountain)

Minitab/JMP/Stat-Ease

Excel

ERP systems

Job description

Job DetailsLevel: ExperiencedJob Location: Warrington, PA 18976Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $100,000.00 - $125,000.00 SalaryTravel Percentage: NegligibleJob Shift: M-F / 1st shiftJob Category: ManufacturingPolysciences 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.

Process Engineer II

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.

What We Offer

Culture

• Great people
• Peer to Peer Recognition
• Broader, hands-on work experience
• Clean and Modern Equipment & Labs
• Fun company events
• Competitive Wages & Generous Year-end Bonus
• Comprehensive Benefits

Comprehensive Benefits

• 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
• Accident, Hospital Indemnity, & Critical Illness
• Paid Time Off
• Paid Parental Leave
• 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.

QualificationsQualifications

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

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

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

Lift/Carry Demands

Frequency:

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