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Sr Process Engineer

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Job ID R0035819 Date posted Jun. 15, 2021 Location Social Circle, Georgia

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Job Description

   The position will be a team member of the Process Engineering group.  Process Engineering is responsible to ensure that the manufacturing equipment/systems used in the production, storage, testing and distribution of products are fit for purpose in accordance with company standards and industry regulatory requirements.

The  Filling Engineer you will be responsible for the design, purchasing, installation, troubleshooting, qualification, operation and maintenance of process equipment and systems including, but not limited to, manufacturing equipment such as:

  • Asceptic Filling (i.e Rigid Container, Paper Board Container, Semi-rigid plastic, Flexible Plastic Containers)
  • Cleaning System (i.e COP (Clean out of Place), CIP (Clean in Place))
  • Decontamination System (i.e VHP ( Vapor hydrogen peroxide)
  • Sterilization System ( SIP (Sterilization in Place), Autoclave (Steam Sterilization))
  • Clean Room Environment (ISO 5, ISO 8 AND ISO 9)

The engineer will lead trial runs, project start-ups (FATs/SATs), resolving manufacturing issues, and in packaging validation efforts. Additionally, you will be required to lead or own change control, non-conformances and CAPA activities working with Quality and Global Operations.  This position will provide support to manufacturing system.  The Engineer will implement area and system improvements through strict adherence to Standard Operating Procedures and cGMP’s in a Pharmaceutical Manufacturing facility.

Responsibilities

Key Accountabilities

  • Develop, evaluate and implement cost-effective engineering equipment design solutions for a manufacturing facility in a fast-paced cGMP, biotechnology environment.
  • Work independently with some to limited supervision.
  • Define and implement projects.  Define scope, cost, justification and benefit of projects. 
  • Own and implement change control documentation and projects.   Drive projects to completion to meet timeline and budget objectives.
  • Create and maintain specifications (Design/Functional/System) and drawings New Package Introduction
  • (P&ID/Layout/etc)
  • Perform factory and site acceptance tests (FAT/SAT), installation, commissioning, debugging, and optimization.
  • Support Validation scope definition, development and execution.
  • Technical Lead for a cross functional team for implementation of projects.
  • Create and update written Standard Operating Procedures (SOPs) related to project assignments.  Train maintenance and manufacturing personnel.
  • Provide technical support for equipment in manufacturing, as second level support.  Act as the subject matter expert (SME) of equipment.  
  • Assist/Lead in Quality and Safety investigations

Education and Experience Requirements

  • Bachelor's degree in Engineering discipline required. 5+ years of related experience. Some leadership experience preferred for supervisory roles.

Key Skills, Abilities, and Competencies

  • Must have a demonstrated track record of successfully executing engineering projects, and supporting facility issues, in a FDA-regulated manufacturing environment.
  • Possess knowledge of core principles in various engineering disciplines including manufacturing (i.e. cell culture/fractionation//purification/aseptic filling/packaging/cGMP facility design), support systems (WFI/RO/clean steam/compressed gases/HVAC) and facility design.
  • Possess knowledge on manufacturing process as follows:
  • Asceptic Filling (i.e Rigid Container, Paper Board Container, Semi-rigid plastic, Flexible Plastic Containers)
  • Cleaning System (i.e COP (Clean out of Place), CIP (Clean in Place))
  • Decontamination System (i.e VHP ( Vapor hydrogen peroxide)
  • Sterilization System ( SIP (Sterilization in Place), Autoclave (Steam Sterilization))
  • Possess Knowledge in Clean Room Environment (ISO 5, ISO 8 AND ISO 9)
  • Must have excellent organizational, verbal and written communication skills; Able to efficiently communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project.
  • Must have the ability to effectively participate in Engineering projects and drive results.
  • Direct experience with manufacturing operations and biotechnology processes is strongly preferred.
  • Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.), as well as be experienced applying project management methodology.
  • Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
  • Knowledge of programmable logic controllers, DCS, instrumentation and controls highly desirable.
  • Has the ability to prioritize multiple tasks and work on multiple projects simultaneously.
  • Must be a self-starter, detail oriented and able to work independently.
  • Must embrace working in a fast-paced, team-oriented, cross-functional environment.
  • Desire Experience with Optima Filling Equipment, Gettinge Steam Sterilizer and ATEC Vessels

Other Job Requirements

  • Some travel may be required for factory acceptance testing, site visits, and training.

This Job Posting excludes CO applicants

EEO Verbiage for US Reqs

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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