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Employer ICDS Recruitment
Job Title LyophilISAtion Process Engineer

Lyophilisation Process Engineer - County Waterford.


Health, Safety and the Environment-
• Comply at all times with the Health, Safety and Environmental policy and associated procedures
• Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do
• Oversee project equipment and processes to ensure safety is built within the design. Attend safety risk assessments as required

Quality Compliance-
• Ensure all work carried out is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines
• Take ownership for quality compliance in all activities you are responsible for
• Oversee project equipment and process commissioning and qualification as per the project VPP

• Will be Subject Matter Expert for IMA Lyofast 5 Freeze Drier from Factory Acceptance Testing to cycle development
• Defining and reviewing equipment specification and associated test documentation
• Troubleshooting equipment with particular emphasis on process cycles (e.g cleaning, sterilizing)
• Strong focus on disciplined root cause analysis
• Development of process cleaning and sterilization cycles

Candidate Requirements
1. At least 15 years’ experience in Freeze Dryers, Autoclaves, Steam in Place (SIP) / Clean in Place (CIP) skids
2. Qualified to a minimum of degree level in an Engineering discipline; postgraduate qualification an advantage
3. Possess an extensive knowledge of and experience with Freeze Driers, ideally IMA based units
4. Experience with commissioning and validation of Lyophilisation equipment
5. Possess a high level of proficiency in automation and knowledgeable on GAMP5 and CFR21 part 11 compliance

This job originally appeared on
Location Waterford
Date Added 159 days ago
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