Role: Senior Process Engineer
Location: Castletroy, Limerick, Ireland, V94 6R68
Fully onsite position.
Required:
* Minimum a Level 8. B.Sc. or B.Eng. honors degree qualification in Physics/Chemistry/Biological Science or Mechanical/Material/Process Engineering, with a demonstrable track record of delivering results.
* Strong understanding of GMP-regulated manufacturing environments
MUST have experience:
* Minimum of 7 years' experience working in a GMP environment as an Engineer.
Description:
As a member of the process engineering team, you will work within an assigned value stream with specific accountability for process improvement, providing technical support to solve process issues, and supporting internal and inter site product transfers.
Key responsibilities:
* Responsible for providing technical leadership within a production value stream and support/lead the following:
* Identification and implementation of process related continuous improvement activities that improve product quality and grow overall equipment effectiveness.
* Engage with personnel in the identification and resolution of corrective/preventative actions that address any process quality related manufacturing issues.
* Systematically solve problems and use data in support of your decision making. You will enjoy taking the initiative and yet possess the collaborative and influencing skills needed to be a key contributor to cross-functional teams.
* Ensure the delivery of high quality, new and innovative products to our customers, in a timely -and cost-effective manner across multiple product value streams
* Project management, planning and co-ordination of multiple projects, within a matrix environment, including change management via quality systems.
* Apply troubleshooting expertise to resolve complex equipment, systems and process problems using strong statistical and analytical methodologies.
* Communicate details of findings throughout the organization.
* Process validation of products on new and/or existing production lines.
* Keep up to date on the latest process engineering developments and technologies and will leverage breakthrough ideas that set new performance standards.
* Engage with the appropriate personnel in the identification and resolution of corrective/preventative actions that address quality, technical, and manufacturing issues.
Key requirements:
* Good Project Management skills, FPx or other, are required with a demonstrated ability to lead cross functional team effectively.
* Good interpersonal skills and ability to relate well to people both individually and in a team environment
* Good problem-solving methodology and able to manage multiple activities at one time
* High level of self-motivation required.
* Possess the collaborative and influencing skills needed to be a key contributor to cross-functional teams.
* Has a good working knowledge of MS Office suite.
* Previous experience in the use of 'black belt' type statistical techniques (DOE, Process Capability Analysis, Hypothesis Test methods) and problem-solving methodologies (DMAIC).
* Familiarity with Process validation in a regulated medical device / pharmaceutical environment