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May 26 2018

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Job description:

   » Job ID.:15350912
   » Employer ID.:RI/JO-1805-409000
   » Published:17-MAY-2018
   » income:NEGOTIABLE
   » Job location:LIMERICK
   » Employment Type:PERMANENT


You will have at a minimum a Level 8. B.Sc. or B.Eng. honours degree qualification in Physics/Chemistry/Biological Science or Mechanical/Production/Manufacturing/Biomedical Engineering, with a demonstrable track record of delivering results and a minimum of 8 years practice. Ideally you will have practice within an FDA or HPRA regulated, GMP manufacturing environment supporting the production of active pharmaceutical ingredients or drug-leading combination medical device products.

As a Staff Engineer for Combination Products, in a typical day:
You will ensure the delivery of high quality, new and innovative products to our customers, in a timely and cost-effective manner. You will be a core team member in manufacturing platform development projects and supporting NPI projects, with specific accountabilities for the areas of equipment design, development and GMP compliance.
The candidate must:
Have a broad theoretical expertise and practice with regulated pharmaceutical products
Be familiar with pharmaceutical process equipment or combination product manufacturing equipment
Be creative, self-motivated, intuitive, capable of independent work, yet effective in diversified project team environments
Can draw conclusions from data and course next steps
Have good decision-making skills
Have practice in managing internal and external pharmaceutical manufacturing projects
Have strong written and verbal communication skills
Can manage multiple priorities and change and shift priorities when necessary
Be agile and can adapt to new corporate culture
Meet high professional and ethical standards.

You will be expected and encouraged to keep updated on the latest manufacturing engineering developments and technologies and to proactively bring best practice methodologies, procedures, processes and equipment into the organisation.

this function is recognised within the organisation as being of key strategic importance in terms of enabling the business to remain competitive and grow market share.

You will be responsible for providing technical leadership abilities and have ownership for the following:
Executing to combination product manufacturing projects on time, in scope, and within budget with
responsibilities in project leadership abilities, technical engineering, and/or design transfer
Provide technical leadership abilities on material compatibility studies for API wetted components.
Working closely with other disciplines, apply troubleshooting skills to resolve equipment,
systems and process problems using strong analytical methodologies.
Support the NPI process.
Identifies areas of project risk, escalates issues and risks in an expedient manner, and actively
proposes solutions.
Identification and implementation of continuous improvement activities that increase product
quality, quantity and growth of overall equipment effectiveness.
Engage with personnel in the identification and resolution of corrective/preventative actions that
address quality, technical, and manufacturing issues.
Project management, planning and co-ordination of multiple projects, within a matrix environment.
Implementation of safety/environmental requirements on new and existing equipment.
Communication of findings all over the organisation.
Support other disciplines in the process of Quality and Regulatory Approval for new combination
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Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Limerick
Company Type Employer
Post Date: 05/17/2018 / Viewed 15 times
Contact Information
Company: CPL

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