Biologics Process Equipment Engineer

AbbVie; Sligo; On-site; EUR 70,000 - 95,000; Full time

Job summary

AbbVie in Ballytivnan, Sligo is seeking a Biologics Process Equipment Engineer for a permanent, onsite role reporting to the Engineering Manager.

You will support pharma operations, develop and validate process and equipment documentation, lead commissioning and transfer activities, and collaborate across quality, operations and vendors to ensure reliable manufacturing. This position requires a hands-on engineer with strong problem-solving and project leadership skills.

Qualifications

• 3rd level qualification in the relevant discipline.
• 4+ years’ experience in a Pharma/Bio Pharma environment.
• Ability to work across multiple different departments.

Responsibilities

• 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 site
• 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 foller equipment installation integration and co-ordinate vendor supervision as required
• Support 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 requirements
• Participating 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 performance
• Investigate 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.

Skills

Pharma/Biopharma experience

Cross-functional collaboration

Education

3rd level qualification in relevant discipline

Job description

AbbVie in Ballytivnan, Sligo is seeking a Biologics Process Equipment Engineer for a permanent, onsite role reporting to the Engineering Manager.

You will support pharma operations, develop and validate process and equipment documentation, lead commissioning and transfer activities, and collaborate across quality, operations and vendors to ensure reliable manufacturing. This position requires a hands-on engineer with strong problem-solving and project leadership skills.