Manufacturing Engineer - Process Development
Job Description
We are seeking a highly skilled Manufacturing Engineer to join our Process Development team. The successful candidate will be responsible for establishing and leading the Manufacturing Technology team, providing engineering support to ongoing requirements for MFG 7, and supporting future tech transfer projects into MFG 7.
Responsibilities
* Assist in site start-up and project-related activities
* Support package owners on vendor management and equipment or process-related activities and queries
* Generate equipment verification & validation protocols and reports as required
* Review vendor documentation for completeness and accuracy
* Participate in FAT and vendor-related activities
* Support issue resolution during equipment installation, commissioning, and qualification phases
* Participate/Execute/Lead verification & validation related activities as required
* Support CQV execution team as needed
* Ensure equipment is designed and tested to meet the requirements of the process, to ensure that the equipment continues to run as intended, that it is appropriately validated and maintained in that validated state
* Coordinate the delivery of a robust process and reliable equipment in support of a Right First Time Operating Unit
* Main point for communications with the Core Engineering group for MFG 7
* Implement equipment CAPAs and performance improvements
* Execute and lead equipment verification, validation & revalidation protocols as required
* Provide equipment technical support and troubleshooting
* Provide routine Automation support, troubleshooting, and maintenance
* Champion and drive the implementation of Global Requirement Program tools and techniques within the Operation Unit
* Drive the use of PI to provide business efficiency
* Identify equipment improvement projects for Core Engineering Unit
* Work with the portfolio management process to identify projects/support demands from the Core Units
* Champion and Support Energy saving programs/projects within the Operating Unit
* Write equipment assessments to support investigation closure
* Conduct Investigation Trending
* Change Control write up and close out
* Lead / provide SME input into cross-functional teams investigating manufacturing process, environmental and water monitoring deviations including authoring investigation reports, technical assessments, and summaries
* Ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented
* Participate in cross-functional project teams as applicable
* Provide input and work with the MFG leadership team to deliver the MFG objectives
* Support audit preparation
* Cross functional collaboration and leadership skills
* Developing and maintaining a database for investigations, or other required department tracking and data analysis needs, as applicable
* Complete biennial review and PQS updates
* Support the disposition process
* Perform all duties in accordance with GMP requirements, SOPs, and controlled documents
Required Skills and Qualifications
* Third level qualification in a Science or Engineering related subject
* Minimum of 8 years experience in a large-scale in a Biopharmaceutical/pharmaceutical facility
* Ideal experience in establishing a Manufacturing Technology team in a greenfield context of similar size and scale
* Excellent communication skills including computer literacy and ability to work independently and in a team
* Thorough knowledge of current Good Manufacturing Practices (cGMP)
* Experience and knowledge of Delta V MCS platform preferred
* Familiarity with Chromatography and Ultra filtration production operations is desired
Benefits
Bonus, life assurance, parking, pension, VHI benefits
We offer a range of benefits to support your overall health and wellbeing.
Find out more about our benefits.
Others
Must be willing to travel as required internationally to fulfill the responsibilities of the position
Skills: Analytical Problem Solving MFG Process Development Engineering GMP