AbbVie Bio Process Equipment Engineer in Ballytivnan, Ireland
Bio Process Equipment Engineer
Ireland, Connaught, Ballytivnan
Do you want to work for the No.1 Great Place to Work in Ireland while also being part of a new expanding Biologics facility in Sligo? If yes is the answer to this question then this may be the role for you!
We are currently sourcing a Bio Process Equipment Engineer to join our expanding team in Ballytivnan, Sligo. In this role, you will be the process and equipment engineering Subject Matter Expert for vial filling and isolator equipment from design phase to equipment handover.
Review vendor design documentation to ensure compliance with process and technical specifications. Lead the FAT and SAT activities ensuring the equipment is design, fabricated and tested to meet the technical requirements of the project
Support filler equipment installation integration and co-ordinate vendor supervision as required
Participate in design and process project conversations to ensure reliability by design is built in prior to equipment arrival.
Leadership of manufacturing and validation activities during project life cycle.
Support of technical transfers for future product introductions to the site.
Interface with vendor to ensure that equipment/facility designs are aligned and to ensure efficient transfer of information between vendor and site
Support the development of the project commissioning and validation plan.
Review all process related validation protocols for completeness and accuracy.
Assess and own the relationship between process requirements and unit operation equipment.
3rd Level Degree in Mechanical or Chemical Engineering (or relevant discipline)
5 years of total combined experience in Process / Equipment or Manufacturing Engineering within a Pharmaceutical organization
3 years experience in the manufacturing environment of a Biologics plant
Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, and sterilization operations preferable.
Experience in new product introductions (drug product) to pharmaceutical facilities is desirable.