Biologics Process Equipment Engineer

Team Horizon is seeking a Biologics Process Equipment Engineer for a leading pharmaceutical company in Sligo.

Why you should apply:

• You will join an innovative team, working among a diverse group of visionaries, thinkers and doers, working on developing pioneering solutions that lead to shared success.


• They put their people first and live their diversity and inclusion values embracing all perspectives.

What you will be doing:

• 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 meet the requirements of 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.


• Liaising 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.


• 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.


• Any other dutires as assigned

What you need to apply:

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


• At least six (5) years of total combined experience in Process / 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, and sterilization operations preferable.


• Experience in new product introductions (drug product) to pharmaceutical facilities is desirable.#


• Requires proven problem-solving skills under the pressure.


• The position requires detailed evaluation of a number of viable solutions to each problem


• Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.


• Requires a very high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.

Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.