You will have a key role in ensuring the on-going validation compliance of equipment, systems and processes at Genzyme Ireland in both solid dosage forms and sterile products manufacturing.
Capable of troubleshooting validation issues associated with projects, process development etc.
Designs, implements and executes validation studies for manufacturing and control equipment.
Provide technical assistance on current US FDA and EU validation requirements for Fill Finish manufacture and lyophilization.
Ensure that the validation status of equipment and systems are in compliance with c GMP at all times.
Requirements:
3rd level Science or Engineering qualification.
You will have 8-10 years experience working in a Healthcare Manufacturing Environment, ideally part of which would be in the pharmaceutical sector.
Sterile experience preferred.
Job Description
You will have a key role in ensuring the on-going validation compliance of equipment, systems and processes at Genzyme Ireland in both solid dosage forms and sterile products manufacturing.
Capable of troubleshooting validation issues associated with projects, process development etc.
Designs, implements and executes validation studies for manufacturing and control equipment.
Provide technical assistance on current US FDA and EU validation requirements for Fill Finish manufacture and lyophilization.
Ensure that the validation status of equipment and systems are in compliance with c GMP at all times.
Requirements:
3rd level Science or Engineering qualification.
You will have 8-10 years experience working in a Healthcare Manufacturing Environment, ideally part of which would be in the pharmaceutical sector.
Sterile experience preferred.
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
