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 duties 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 five (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 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.