Process & Project Engineering Manager

We are currently partnered with an innovative Biotech in London, in their search for an experienced Process and Project Engineering Manager. Primary Responsibilities Coordinate and prioritize process and project engineering activities to support capital projects and site operations. Provide mentorship and guidance to Process and Project Engineers. Support capital project design, review processes, and related activities. Deliver clear metrics and reports to senior management as needed. Ensure all processes and equipment are designed, installed, and qualified safely. Manage the Engineering department budget as required. Facilitate process technical transfer activities, including design of experiments, single-use commodity specifications, and setup, as well as support Process FMEA. Assist in the continuous development and implementation of both internal and external engineering specifications and procedures. Maintain adherence to current statutory, regulatory, and company safety and quality standards. Contribute to the implementation, maintenance, and assessment of a framework for compliance and ongoing quality improvement, fostering a right-first-time culture within the engineering area. This aligns with statutory, regulatory, and company standards, including cGMP, Quality Systems, and Health and Safety protocols. Develop and manage strong cross-functional relationships to streamline workflows and reduce time delays. Ensure that personal and team activities comply with GMP, Data Integrity, and Good Documentation Practice (GDP), following all relevant procedures. Oversee training compliance, ensuring both personal and team training is completed in a timely, GMP-compliant manner before tasks are performed. Ensure timely, Right First Time (RFT) completion of all GMP documentation related to Issues, CAPAs, Change Controls, BMRs, and audit/inspection actions within the area of responsibility. Key Performance Indicators Improvement of Key Performance Indicators (KPIs) related to utility services, equipment availability, facility operations, safety, and quality compliance. On-time delivery of project milestones and deliverables. Development and execution of an asset care strategy, driving profitability by reducing cost-per-unit metrics. Key Competencies Problem Solving : Effectively identifies and resolves issues, using data analysis and creativity to develop alternative solutions; collaborates well in team problem-solving. Leadership : Demonstrates self-confidence and inspires others, providing feedback and recognizing achievements. Cost Awareness : Works within budget constraints, implements cost-saving initiatives, and contributes to overall profitability and resource conservation. Motivation : Sets challenging goals, persists through obstacles, and upholds a standard of excellence. Planning/Organizing : Efficiently prioritizes tasks, plans for resources, sets goals, and develops actionable, realistic plans. Professionalism : Approaches others with tact, manages pressure well, respects others regardless of role, and follows through on commitments. Quality Management : Seeks out opportunities to enhance quality, demonstrates thoroughness, and promotes accuracy. Innovation : Shows creativity and resourcefulness, generates improvement suggestions, and develops innovative solutions. Oral Communication : Communicates clearly, listens well, and participates effectively in discussions, presentations, and meetings. Written Communication : Writes clearly, accurately, and effectively, adapting style to the audience and presenting data clearly. Job Details Direct Reports : Approximately five (subject to departmental needs). Financial Authority : As defined by the approved delegation of authority for a managerial role. Experience and Professional Background Education : Degree in an engineering or science discipline. Safety and Compliance : Knowledge of safety requirements per HPRA/FDA and Health & Safety Executive guidelines, in accordance with protocols. Technical Expertise : Comprehensive knowledge of biopharmaceutical and pharmaceutical processes, particularly with cleanroom equipment. Start-Up Experience : Experience in a start-up environment is preferred. Industry Experience : Minimum of five years in a biopharmaceutical environment in a Process Engineering role. Leadership Experience : Proven leadership in project or operational settings. Commissioning and Qualification : Familiarity with facility equipment commissioning and qualification in a pharmaceutical environment. Project Management : Strong project management skills required. Fill-Finish Operations : Experience in biopharmaceutical fill-finish operations is preferred.