Job Descriptions

Every day, we rise to the challenge to make a difference and here is how the Senior Manufacturing Engineering Manager role will make an impact:

Key Responsibilities:

• Responsible for leading/managing a team of Engineers in support of a diverse range of manufacturing equipment and automated systems.
• Develop and manage staff through hiring, managing performance, including developing talent and providing clear expectations.
• Work in close collaboration with other related functions to deliver required outputs on a 24/7 shift basis.
• Employ sound technical expertise and structure in support of equipment/process troubleshooting and performance.
• Work in close collaboration with equipment vendors to address defects and performance issues.
• Support preparation of equipment performance reports and data to drive continuous improvement initiatives.
• Lead Engineering response to equipment triage events, investigations and CAPA.
• Leading execution of continuous improvement, and corrective work in support of the manufacturing processes.
• Define manufacturing engineering teams’ governance and procedure, supporting both internal and external regulatory audits and to develop remediation plans.
• Qualification and Validation support for process improvement, corrective work, and projects.
• Supporting the change management process when applicable while adhering to all relevant regulatory requirements for Engineering work within the manufacturing area.
• Actively promotes and participates in cross functional teamwork as an influential team member.
• Continuously improve department processes and advance standardization related to equipment support, ensuring systems comply with regulatory guidelines and Legislative Environment, Health, and Safety requirements.
• Investigates and supports safety incidents or escalations, delivering reports to summarise root cause and corrective/preventive actions.
• Act as deputy for the Engineering Director as required.

Skill Requirements/Competencies:

• The ideal candidate will be a Mechanical/Manufacturing/ Engineering graduate with 5+ yrs. experience in a high speed, highly automated drug, or medical device fill/assembly/packaging operation within a highly regulated industry.
• Demonstrable experience of managing a diverse team of engineering professionals, with a total commitment to Safety and quality while always maintaining a high standard of work.
• Proficient and experienced in delivering projects and continuous improvement initiatives within manufacturing, with knowledge and competencies in quality, validation, and maintenance systems.
• A motivated and flexible person who can formulate detailed plans with minimum supervisory influence and manage them through to completion.
• Flexible, adaptable, and accessible
• Demonstrated effective communication and team-working skills including the ability to work effectively and influence decisions across functions, communicating effectively through verbal and written means.
• A history of developing efficient, innovative, and creative solutions to complex and challenging engineering problems, using established tools and frameworks. Lean/Six sigma certification would be advantageous.
• A working understanding of appropriate regulatory requirements, including 21 CFR Parts 210/211, ISPE/ICH Guidelines (including Quality by Design approach) and EudraLex would be an advantage.

Skills

• Self Motivated
• Flexible and adaptive

Experience

• 5