Our client whose single use multi-product biotech facility is based in Dunboyne, County Meath. 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 its Governance Pillars in People, Safety, Quality, Delivery and Cost.
- Support the Manufacturing Lead with interviewing and hiring and will help manage intern roles.
- Drive continuous improvements and will be a key stakeholder at enterprise meetings.
- 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.
Qualifications & Experience:
- The successful candidate will have 5 years’ experience in a GMP regulated environment with strong technical knowledge of upstream and downstream processing.
- Familiar with MES, Delta V and electronic batch records.
- Strong technical writing skills and be proficient in 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.
To apply for this job email your details to email@example.com.