Major Activities

• Coordinate and prioritize Process and Project engineering activities to support capital projects and site operations.
• Provide support and guidance to the Process and Project engineers.
• Support Capital project design and review activities.
• Provide clear metrics and reports to senior management as required.
• Ensure that processes and equipment are designed, installed and qualified in a safe manner .
• Manage Engineering department Budget as required.
• Support Process technical transfer activities, such as Design of experiments, Single use commodity specifications and Setup, Support Process FMEA.
• Assist with the continuous development and implementation of the internal and external Engineering specifications and procedures.
• Maintain all current statutory, regulatory and company safety and quality standards.
• Assist with the implementation, maintenance and measurement of a framework for compliance and ongoing improvement in quality performance and right first-time culture within the engineering area. This will be in accordance with statutory, regulatory and company standards, procedures and systems regarding relevant cGMP, Quality Systems and Health and Safety in the workplace.
• Develop and manage strong relationships across teams to remove barriers and time lags.
• Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
• Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken
• Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state

Key Performance Indicators

• Improving Key Performance Indicator's for building utilities services; equipment availability and performance; safe and quality compliant facility operations.
• Supporting project deliverables delivery on time.
• Development of an asset care strategy and growing profitability through reducing the cost per unit measures

Key Job Competencies

• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyses information skilfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
• Leadership - exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
• Cost Consciousness - works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.
• Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
• Planning/Organizing -prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
• Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
• Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
• Innovation - displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
• Oral Communication - speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
• Written Communication -writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

Job Responsibilities

• Number of direct Reports - (5) with some variation possible in line with department workload requirements. Financial authority - as per the approved delegation of authority limit defined for Manager role.

Experience / Professional Background

• Education - Qualified to Degree in an engineering or Science discipline.
• Management of safety requirements of the HPRA/F.D.A. and Health & Safety Executive, as defined in MeiraGTx procedures.
• Comprehensive practical and theoretical background on a wide range of Biopharmaceutical and pharmaceutical Process, cleanroom equipment is essential.
• Experience working in a start-up environment is desirable.
• Min 5 years' Experience of working within a Biopharmaceutical environment in a Process engineering role.
• Experience in a leadership position in projects or an operational environment.
• Experience with the requirements of commissioning and qualification of Facility equipment in a pharmaceutical environment.
• Strong Project Management ability required
• Experience with Fill Finish operations in Biopharmaceutical is desirable.