AbbVie Process Equipment Engineer in Sligo, Ireland
Process Equipment Engineer
Ireland, Connaught, Sligo
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At AbbVie Ballytivnan, we are expanding our facility into a multi-million dollar state of the art Biologics plant that will bring groundbreaking scientific research to real-life solutions for our patients.
We are now recruiting a Process Equipment Engineer. The successful candidate will provide technical assistance to the manufacturing areas related to the manufacturing process and equipment. You will be responsible for providing solutions to complex issues in a highly technical and regulated Biologics Plant as well as developing and implementing changes that will improve equipment performance and enhance product quality.
Develop and modify procedures as needed to support the manufacturing operation.
Participate in process, equipment, and facilities validation efforts and project implementations.
Process and equipment engineering Subject Matter Expert for Lyophilizer / Freeze Drying equipment from the design phase to equipment handover.
Review, and approve process flow diagrams (PFDs), specifications, layouts, and P&IDs.
Interface with the vendor to ensure that equipment/facility designs are aligned and to ensure efficient transfer of information between the vendor and site
Review vendor design documentation to ensure compliance with process and technical specifications. Lead activities ensuring the equipment is designed, fabricated and tested to meet the technical requirements of the project
Support Lyophilizer / Freeze Drying equipment installation integration and co-ordinate vendor supervision as required
Support the development and execution of the project commissioning and validation plans. Develop commissioning plans for all process-related equipment ensuring that plans meet the requirements of Abbvie’s Good Engineering Practice (GEP)
Review all process-related validation protocols for completeness and accuracy. Execute protocols on a timely basis to meet the project schedule requirements
Participating in design and process project conversations to ensure reliability by design is built-in before equipment arrival.
Provide leadership in manufacturing and validation activities during the project life cycle.
Investigate process exceptions or equipment malfunction incidents affecting the process.
To liaise with Internal/External Engineering personnel and contract maintenance providers in maintaining, troubleshooting and installing/commissioning equipment.
Support the Production Team in ensuring that manufacturing equipment is maintained to meet the output and yield requirements.
Adhering to all relevant policies relating to Quality & Safety.
Ensure successful external inspections, and Division and Corporate audits.
Supervision of external contractors.
Education & Experience Required:
Engineering degree in a related discipline.
At least 5 years of total combined experience in Process / Equipment or Manufacturing Engineering of a Pharmaceutical or highly regulated industry.
Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill-finish, Lyophilisation, sterilization operations preferable.
Experience in clean utilities is desirable.
Knowledge of adhering to quality and regulatory requirements.
Strong communication skills both verbal and written are required for the execution of this role.
Understands and supports the principles of Perfect Performance.
Equal Employment Opportunity Employer: At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate based on race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Job Type: Experienced
Job Level Code: IC