PE Global is currently recruiting for a Process Engineer for a leading multi-national Biotech client based in Meath.
This is an initial 11-month contract position.
ROLE:
- This role will be part of a Manufacturing Self Directed work team/ Hub in anew state of the art single use multi-product biotech facility in County Meath, Ireland. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
- This role will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to achieve our Governance Pillars in People, Safety, Quality, Delivery and Cost.
- Will work with a team of Manufacturing Specialists and play a key role in supporting the site in Engineering and PPQ batch campaigns. Support MFG Days lead with interviewing and hiring and will help manage intern roles.
- They will look to drive continuous improvements and will be a key stakeholder at enterprise meetings and act as a designee for the MFG Days Lead.
This role will deliver key metrics such as
- Compliance Excellence – Deviation Management, Change Management and QMS Integration
- EHS Event Investigation
- GMP Readiness
- Audit preparation
- Problem Solving and Root Cause Analysis
- Next Product Introductions
- Technical Support and Troubleshooting for Upstream and Downstream Processing
- Trend Identification and Issue Resolution
- Project Management
REQUIREMENTS:
- 5 years’ experience in a GMP regulated environment with strong technical knowledge of upstream and downstream processing.
- Experience with MES, Delta V and electronic batch records.
- Strong technical writing skills and be proficient in the following areas – Documentation Management, Change Management, Deviation Management.
- Proven track record of utilising data to drive issue resolution and decision making. Strong stakeholder management skills are desirable.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to sean.molloy@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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