Clean Utilities Engineer (Biologics)

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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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 now recruiting a Clean Utilities Engineer (Biologics) to join our diverse Team in the Sligo Ballytivnan site. Reporting to the Biologics Engineering Manager, you will provide technical assistance to the manufacturing areas related to the manufacturing process and equipment. These areas are highly dependent on technique, detailed procedures, equipment, and controls. The position requires dealing with difficult technical problems in a highly technical and regulated Biologics Plant. This position requires developing and implementing changes that will improve equipment performance and consequently product quality.

To ensure continual compliance with the policies relating to Personnel, Quality, Engineering, Safety and Finance. The Clean Utilities Engineer will take ownership for clean utilities (Purified Water, Water for Injection, Clean Steam, High Quality Compressed Air and Nitrogen Distribution) and to work as a team member in line with all safety, regulatory and organizational requirements.

Are you intrigued? Do you want to learn more? 
A snapshot of your key responsibilities as a Clean Utilities Engineer (Biologics) would be:

• Clean Utility Engineering Subject Matter Expert from design phase to equipment handover. 


• Review and approve process flow diagrams (PFDs), specifications, layouts, and P&ID’s.


• SME in mechanical, electrical and pneumatic utility systems.


• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.


• Lead, promote, participate, and supervise the implementation and maintenance of the relevant safety programmes.


• Delivery of safety, performance, and quality goals.


• Support clean utility equipment installation, integration and co-ordinate vendor supervision as required.


• Develop and modify procedures as needed to support the clean utility area.


• Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy. Execute protocols in a timely basis to meet the project schedule requirements.


• Participate and lead clean utility project implementations. 


• Leadership of clean utility and validation activities during 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, trouble shooting and installing/commissioning equipment.


• Support the Production Team in ensuring that utility equipment is maintained to meet requirements.


• Present on clean utility area in regulatory inspections ensuring successful outcomes.


• Cross functional collaboration with QC Micro, Operations, QA and Engineering.



 
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So, what do you need to do this role? 

Education & Experience  

• A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable).


• At least five (5) years of total combined experience in Clean Utility / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.


• At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant. 


• Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable. Experience in clean utilities is essential.


• Requires proven problem-solving skills under the pressure. This person is an innovative thinker, has a high level of attention to detail and demonstrates a strong commitment to quality.


• This person has strong communication skills and the ability to work cross functionally both verbal and written are required for the execution of this role.


• Strong interpersonal skills are required.



 
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AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of 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, status as a protected veteran, or any other legally protected group status.