Director of Engineering & Maintenance Do you want to lead engineering and maintenance excellence within a regulated pharmaceutical manufacturing environment? Are you experienced in improving equipment reliability, reducing deviations and solving complex manufacturing problems? Do you enjoy developing high-performing technical teams while driving measurable improvements in manufacturing performance? Fraser Dove International is partnering exclusively with an established pharmaceutical manufacturing organisation. Operating in the United States, they are committed to delivering safe, compliant and reliable sterile pharmaceutical manufacturing. Our client is seeking an experienced leader to drive engineering and maintenance excellence, improve manufacturing asset reliability and provide technical leadership across sterile pharmaceutical operations. Discover more about our Director of Engineering & Maintenance opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed. Your objectives: As the Director of Engineering & Maintenance, you will be measured against the following objectives: Improve manufacturing equipment reliability and uptime by strengthening preventive and predictive maintenance, reducing repeat failures and improving maintenance performance. Reduce manufacturing deviations and recurring technical issues through disciplined root cause analysis, effective Corrective and Preventive Action (CAPA) and sustainable engineering solutions. Build a high-performing engineering and maintenance function that improves manufacturing performance, develops technical capability and delivers against operational and quality priorities. Job Fit Success Factors: Engineering and maintenance leadership: 10+ years of progressive engineering and/or maintenance leadership experience within pharmaceutical, biotechnology, medical device or another regulated manufacturing environment, including proven success leading technical teams. Sterile manufacturing and Good Manufacturing Practice expertise: Strong knowledge of engineering and maintenance practices in a Good Manufacturing Practice (GMP) environment, with sterile manufacturing or aseptic processing experience strongly preferred. Equipment reliability and maintenance excellence: Demonstrated expertise in equipment reliability engineering, preventive and predictive maintenance, reliability-centred maintenance and Computerised Maintenance Management Systems (CMMS).Technical problem-solving and quality improvement: Strong command of root cause analysis, Corrective and Preventive Action (CAPA), deviation reduction, risk management and structured problem-solving methods such as Failure Mode and Effects Analysis (FMEA), Lean Manufacturing and Six Sigma. Manufacturing performance improvement: Ability to improve equipment uptime, Overall Equipment Effectiveness (OEE), throughput, batch performance and maintenance compliance using statistical analysis, performance trends and data-led decision-making. Cross-functional technical leadership: Ability to partner effectively with Operations, Quality Assurance, Quality Control, Validation, Manufacturing Science and Technology (MSAT), Supply Chain and other stakeholders while acting as a senior technical escalation point. Engineering education: Bachelor of Science (BSc) degree in Engineering or a related technical discipline. A master's degree in Engineering or a technical field is preferred.
What you will do:
As the Director of Engineering & Maintenance, your duties and responsibilities will include: Lead, coach and develop engineering and maintenance teams, setting clear goals and building a culture of accountability, technical excellence and continuous improvement. Lead preventive, predictive and reliability-centred maintenance programmes to improve equipment uptime, maintenance compliance, spare parts management and manufacturing reliability. Serve as the technical leader for significant equipment failures, manufacturing disruptions and investigations, using structured root cause analysis to eliminate recurring issues. Partner with Quality, Manufacturing and Validation teams to reduce deviations and nonconformances, improve CAPA effectiveness and strengthen right-first-time manufacturing performance. Improve manufacturing throughput, equipment utilisation, batch yields, changeover performance and productivity using Lean Manufacturing, Six Sigma and data-led analysis. Develop long-term equipment lifecycle and reliability plans, monitor critical asset health and provide engineering support for commissioning, qualification, troubleshooting and operational readiness. Establish and monitor Key Performance Indicators (KPIs), including equipment uptime, Overall Equipment Effectiveness (OEE), maintenance compliance, deviation reduction and batch success, while ensuring activities meet regulatory and Good Manufacturing Practice (GMP) requirements.
What you will bring:
These are the skills and experience you will need to succeed as the Director of Engineering & Maintenance:10+ years of progressive engineering and/or maintenance leadership experience within pharmaceutical, biotechnology, medical device or another regulated manufacturing environment. Demonstrated success leading engineering and maintenance organisations, with experience building and developing high-performing technical teams. Strong knowledge of equipment reliability engineering, preventive and predictive maintenance, reliability-centred maintenance and Computerised Maintenance Management Systems (CMMS), with sterile or aseptic manufacturing experience strongly preferred. Strong technical problem-solving skills, including experience with root cause analysis, deviation and Corrective and Preventive Action (CAPA) management, Lean Manufacturing, Six Sigma and risk management. Ability to use statistical analysis, performance trends and manufacturing data to make sound decisions while balancing immediate operational requirements with long-term reliability objectives. Bachelor of Science (BSc) degree in Engineering, including Mechanical, Electrical, Chemical, Industrial, Manufacturing Engineering or another related technical field. A master's degree in Engineering or a related technical field is preferred.
