Process Engineer II

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: Fundamental and critical tasks, duties, and responsibilities necessary for position to be performed effectively.

• 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

-Troubleshooting skills to support commercial production for both the process and associated equipment.

-Ability to design, develop, implement and as needed, oversee systems to improve and sustain commercial chemical manufacturing, cleaning, filling and packaging processes.

-Ability to work collaboratively with a cross functional team (R&D, Quality, QC, Production, EHS, etc.) to ensure improvements align with required design and development process.

-Bachelor’s degree in Chemical Engineering preferred, Industrial or Mechnical accetable.

-Experience working in an ISO 13485 or FDA GMP environment preferred. 

-A minimum of 2-5 years of engineering experience in a manufacturing environment or similar required.

-Familiarity with process scale-up, optimization, cleaning and validation activities required.

-Knowledge of equipment specification, qualification and automation required.

-Ability to lead or supervise a small team of peers and cross-functional groups for day to day tasks and project completion.

-Ability to define, proceduralize and train teams to a process.   

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

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.

Qualifications

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                                    

Salary : $95,000 - $115,000