Manufacturing Engineer for the Pharma industry in Westmeath
Cpl are a working with one of our client partners to help them source an accomplished Manufacturing / Plant Engineer for their pharma product manufacturing site in Mullingar
• Reporting directly to the Director of Manufacturing, you will support the site manufacturing process and develops expertise on manufacturing equipment and interactions with the overall production process.
• You will have a particular focus on Equipment and Process improvements, supporting the site OEE programme as well as being a key stakeholder and contributor to the sites continuous improvement programme.
• The Manufacturing Engineer will support the development of Operations Strategies needed to support activities for the Injection Platform including but not limited to: Design for Moulding/Manufacturing, Cost estimates, Capital requirements, Capacities, Technology, Architecture, Capabilities Analysis, and Materials Sourcing in a regulated Pharma industry
• Support architecture and product development activities by providing operations leadership to the team by conducting analyses, giving technical support and recommendations of effective solutions to operational issues, product cost, and asset utilization
• You will help to develop, maintain and coordinate the tracking of major operational metrics (i.e. balanced score card, capacity utilization, waste and uptime pareto charts, value stream mapping) using an SAP/ERP environment and make improvements as needed to remain aligned to business needs and priorities
• Lead project plans by collaborating with leadership in manufacturing facilities, the leaders within the company (Finance, R&D) and external suppliers/vendors
• Provide a link between the Manufacturing sites, Product Development teams and the Process Development groups on new product development, including satellite design centres, on rapid prototyping, pilot line scale-up and process development, clinical and DV build capabilities
• The Manufacturing Plant Engineer will prepare product and process reports by collecting, analysing, and summarizing information and trends, in support of process improvement.
• You will be required to investigate process deviations and deliver reports to summarise root cause, impact assessment and corrective/preventive actions.
• Assuring product and process quality by testing product and process capabilities; establishing standards; confirming manufacturing processes optimization.
• Providing Technical Training to a high level to all business areas and personnel, ensuring learnings and process improvements are shared.
• Providing Qualification and Validation support for process improvement, corrective work and projects, demonstrating good working knowledge of validation techniques and associated regulatory requirements.
• Investigates safety incidents and delivers reports to summarise root cause and corrective/preventive actions.
• Promoting and implementing Safe Working in all work areas and projects.
• Actively promotes and participates in cross functional teamwork as an influential team member.
The necessary qualifications for this Plant Engineer role are:
• The ideal candidate will be a Mechanical/Manufacturing/ Engineering professional with a minimum of 3-5 years’ experience in a high speed, highly automated drug, medical device or food and beverage fill/assembly/packaging operation
• You will be proficient and experienced in delivering continuous improvement initiatives within manufacturing, with knowledge and competencies in quality, validation and maintenance systems.
• The Manufacturing Engineer will have demonstrated experience in design and execution of technical reports in support of manufacturing process improvement, deviations and problem solving.
• You are a motivated and flexible person who can formulate detailed plans and projects with minimum supervisory influence and manage them through to completion.
• Demonstrated strong team-working skills including the ability to work effectively and influence decisions across functions, communicating effectively through verbal and written means.
• Ideally you will also have a proven track record 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.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
• 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.
If you’re interested in a new and exciting challenge in a dynamic new company who are on an exciting journey and growth path and if Mullingar is a suitable location for you, then please send me your CV in complete confidence.
I will review and reply to you within 24 hours, the role itself is live and the hiring manager will review CV’s and provide feedback within 72 hours.