GXP Systems

Process Engineer

Job Introduction

Due to a new customer contract, we are urgently looking for a Process Engineer  to provide specialist support for equipment qualification and operations initially in a start-up environment.  Also required to provide technical support for clean utilities and facility qualification as needed.

This role focuses on resolving technical and engineering issues, providing technical support and trouble-shooting, investigation closeout and maintaining the qualification status of a new aseptic plant and equipment


Role Responsibility

  • Support the design and implementation of aseptic processing technologies and procedures
  • Lead process equipment commissioning and qualification activities for a new aseptic facility
  • Develop process understanding; perform gap analysis and FMEAs
  • Lead contamination reduction and investigation projects
  • Lead major equipment related investigations and implement equipment CAPA and performance improvements.
  • Develop and support aseptic practice training as necessary
  • Drive the adoption of new aseptic processing technologies and best practices in manufacturing processes
  • Develop metrics to measure and continually improve aseptic processing practices within manufacturing and process development
  • Provide technical guidance on change controls and how they might impact aseptic processing
  • Prepare and review technical and compliance testing protocols and reports.
  • Provide technical training on process and equipment as required by Operations

The Ideal Candidate

Qualifications
  • Provide technical training on process and equipment as required by Operations
  • Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage
Experience
  • A minimum of 4-5 years industrial Engineering experience of which 2-3 years will be in an aseptic processing environment
  • Experience in Fill-Finish of injectable products is highly desirable
Skills & knowledge
  • Technical knowledge (theory and practice) of aseptic manufacturing; experience working in high technology / Engineering disciplines with exposure to Aseptic processing.
  • In depth understanding of Autoclave, CIP and SIP systems, and Clean Utilities
  • Design of Experiment and associated statistical techniques
  • Pharmaceutical product development project life-cycle experience
  • Strong report-writing and verbal communication skills
  • Research skills
  • Innovation and creativity skills; demonstrated ability to provide technical solutions for complex problems through equipment knowledge
  • Project management skills
  • Structured Problem-solving skills – Statistical
  • Proficient in the use of structured problem solving tools such as Process Mapping, RCA (Root cause analysis), FMEA's (Failure Mode effects analysis) etc.
  • Strong knowledge of current Good Manufacturing Practices and US / EU regulations
  • Ability to act as Process Engineer SME in regulatory audits

Package Description

If you would like to join our team of the top engineering and project management experts in the regulated industry, please click on the apply button located at the right hand side of the page.

Alternatively, to apply for a job, you may submit your CV via mail or fax to:

Stericycle GxP Solutions
Human Resources
The Atrium
Blackpool
Cork
Ireland


About the Company

 Stericycle GxP Workforce provide the best engineering experts in their field; experts who like the variety and challenges of working in new and innovative environments; who get the job done and have pride in their achievements.

Located in Cork, Ireland and with customers across global sites, we can offer our Engineers a great place to work with excellent working conditions. Our customers are responsible for some of the most significant medtech & pharmaceutical products of our time, so the projects that our people work on can directly affect patients and improve their quality of life. 

Details

Contract type:
Contract - 12 months
Closing Date:
09/02/2018
Salary:
TBD
Location:
Munster
Job Reference:
GXP/2985
Job Category:

Process Engineer

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