About this role
What you do, is what we need. Making a difference begins here. And takes all of us.
Welcome to AbbVie!
We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.
We are looking for an Biologics Process Equipment Engineer to join our team in Ballytivnan, Sligo. This is a Permanent position. The position reports directly to the Engineering Manager.
This is an onsite role.
Your responsibilities will be:
To work as a team member to support engineering in pharma operations in line with all safety, regulatory and organizational requirements.Develop and modify procedures as needed to support the manufacturing operation.Participate in process, equipment, and facilities validations efforts and projects implementations.Process and equipment engineering Subject Matter Expert for a vial filling and isolator equipment from design phase to equipment handover.Review, and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s.Interface with vendor to ensure that equipment/facility designs are aligned and to ensure efficient transfer of information between vendor and siteReview 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 projectSupport foller equipment installation integration and co-ordinate vendor supervision as requiredSupport the development of the project commissioning and validation plan.Develop commissioning plans for all process related equipment ensuring that plans meets the requirements of Abbvie’s Good Engineering Practice (GEP)Review all process related validation protocols for completeness and accuracy.Execute protocols in a timely basis to meet the project schedule requirementsParticipating 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.Assesses and owns the relationship between process requirements and unit operation equipment.Understands the impact of equipment control systems on processing performanceInvestigate process exceptions or equipment malfunction incidents affecting the process.Liasing with operations, quality and S&T to ensure equipment and process performance is maximized.To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining trouble shooting and installing/commissioning equipment.Implementation of equipment/process upgrade in an environment of continuous improvement.Supervision of external contractors. What you will need:
3rd level qualification in the relevant discipline4+ years’ experience in a Pharma/ Bio Pharma environmentExcellent communication skillsAbility to work across multiple different departments
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html