Pharma Manufacturing Support Engineer

Summary:
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.

Responsibilities:

• 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.