Icon hamburger
Briefcase

Create Job Alert.

Enter your email below to save this search and receive job recommendations for similar positions.
Thank you. We'll send jobs matching these to
Missing Translation: eu_consumer_core.job_alert.duplicate_alert
No Thanks
US
What job do you want?

Create Job Alert.

Get similar jobs sent to your email

Apply to this job.
Think you're the perfect candidate?
Apply Now
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
Process Engineer at Strategic Software Solutions

Process Engineer

Strategic Software Solutions Work From Home, GA Contractor
$68.00 - $72.00 / hour
Apply Now

Create Job Alert.

Get similar jobs sent to your email

REMOTE POSITION


Role: Senior Process Engineer, Manufacturing Technology

Project Support

Industrial Operations, Swiftwater, Pennsylvania, USA


This position of Industrial Operations Senior Process Engineer, in the Manufacturing Technology (Mtech) function of Industrial Operations, is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the company's industrial sites. The mission of MTech is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). Mtech’s function also provides daily support, for manufacturing and QC, toward industrial performance excellence.


• Develops and manages all single use and multi-use system process designs associated with the specific projects. This includes but is not limited to:

o Develops details required for product process system Basis of Design (URS’s, Process Flow Diagrams (PFDs) and Process Descriptions)

o Responsible for the design of single use systems and/or select multi-use systems based on product process requirements (interface with product process owners)

o Assists in execution of functional testing (C&Q of fixed and single use), including the review/approval of test plans, data packs and reports

o Supports project teams in their selection of single use and multi-use systems, including supplier capabilities, shop drawing reviews,etc.


Accountabilities: (Deliverables)

• Responsible for process design and continuous improvements, including:

o URSs, Design of Single Use Systems, Process Flow Diagrams, Process Narratives

o Identifying multi-use equipment

• Author and approved protocol and reports supporting execution of functional testing

• Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.




  • The Job Responsibilities Include: (Responsibilities = How to deliver)

    • Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.

    • Partner with Engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment

    • Provide technical assistance to manufacturing technology for process troubleshooting.


    Education and experience

    Basic Qualifications: 

    • BS in Engineering (chemical, biochemical, mechanical or similar) with a minimum of 7 years industrial experience.


    Preferred Skills:

    • Expertise in process equipment design and implementation, including disposables

    • Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.

    • Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.

    • Experience in equipment start-up, qualification is preferred.

    • Proficient in MS Office 365 software

    • Proficient in communication tools- Outlook and Zoom

    • Proficient in a cGMP documentation system preferably GEODE.

Recommended skills

Engineering Fundamentals
Geode
Office 365
Apply to this job.
Think you're the perfect candidate?
Apply Now

Job ID: SP-PROC ENGINEER-2706

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.