Lead Equipment Engineer (Pharma)
Lead Equipment Engineer (pharma. Youwill provide technical expertise and leadership in ensuring that the equipment and facility requirements of the Process Development group are met and will represent the Process Development group at site and global equipment teams. Key Responsibilities • Display a well-developed knowledge of engineering principles and cGMP requirements. • Become an SME in Process Development equipment and the site systems for equipment introduction. • Generate documentation to support facility/equipment specification, design and commissioning/qualification activities within a cGMP environment. • Apply a project management approach to develop, track and communicate plans for assigned projects, ensuring objectives are achieved on time and in budget. • Lead risk assessment activities involving cross-functional teams and make risk-based judgements on key project activities. • In conjunction with the Process Development process engineers and other key stakeholders, plan, design, specify and oversee the introduction of new facilities/equipment to support the delivery of key programmes and act as the PD representative on cross-functional project teams designated by the site engineering group to source major equipment. • Represent the Process Development department on cross-functional project teams to ensure delivery of key projects. • Analyse and provide resolution of technical issues. • Ensure that budgetary and CAPEX requirements are followed. • Encourage and support contributions from team members, promoting open discussion and collaboration, effectively managing conflict within the team. • Support FDA pre-approval and post-approval inspections by serving as technical expert for development operations. Present, where appropriate, technical data to internal / external audit groups (including HPRA & FDA) and commercial partners. • Present, where appropriate, technical data to internal / external audit groups (including HPRA & FDA) and commercial partners. • Ensure all company and departmental policies and procedures are adhered to. • Effectively communicate to stakeholders project activities and updates. Requirements for this role: • Third level qualification in Science, Engineering or related discipline. • Minimum of 5 years' engineering experience, preferably in the pharmaceutical industry , with detailed knowledge of process equipment and facilities (containment systems design and operation, dust extraction, solvent abatement etc.). • Strong technical and project management skills. • Demonstrated track record in generating technical options to resolve problems, prioritising solutions, selecting optimal solutions and implementing decisions. • Project Management skills an advantage. • Experience of formal risk-based assessment tools an advantage. • Adaptable to changing priorities. • Excellent verbal and written communication skills. This job originally appeared on RecruitIreland.com.
333 days ago