Process Equipment Engineer

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