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's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com . Follow @abbvie onLinkedIn, Facebook ,Instagram ,X andYouTube.

Job Description

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 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.

Qualifications

What you will need:

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

Additional Information

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.