Healthcare Life Sciences
The Production Engineer will play a key role in a new pilot scale manufacturing facility based in Stevenage in the UK that is being commissioned to provide a flexible launch capabilities for a number of new commercial products. This presents an opportunity for an individual with the appropriate skills and experience to play a key role in translating novel products into commercial manufacture.
The Production Engineer will work closely with R&D, product/process development and launch teams to enable rapid translation of breakthrough technologies that will improve the manufacture of medicinal products to benefits patients worldwide. This will require an individual that has an ability to manage development of new production lines whilst the final product formats are in flux.
They will assist the Production Team Leader in the management and development of the production processes to ensure company’s targets and objectives are met to meet customer requirements, ensuring staff comply with health, safety and standard operating procedures. Striving to continually improve using Lean tools to reduce costs, improve production and quality.
• Assist management in the planning and operation of the pilot plant to generate commercial material and transfer new lines into production
• Assisting in generation of commercial materials when required – as a small team in a new facility this may represent up to 50% of role.
• Supporting the Production Team Leader in the running and operation of the facility
• Drive improved product quality by identifying manufacturing issues, developing advanced manufacturing cost-effective solutions, and overseeing successful implementation into production
• Aid in the tracking metrics in their functional area to include labour hour consumption, work order completion, inventory accuracy, throughput, capacity and customer complaints. Work with management, operators and technicians to ensure team goals are met.
• Monitor and improve productivity through the use of Lean Six Sigma or related tools, while ensuring all customer commitments are met in a timely, quality and cost-conscious manner
• Participate in early focus on manufacturability in NPI and/or Advanced Technology programs. Drive rigor in process capability assessment, process layout, tooling and equipment development and QMS Design Transfer execution
• Clearly understand existing processes in order to provide support for manufacturing process technology roadmap
• Ensure regulatory compliance through Qualification & Validation. Responsible for ensuring rigor in determining processes requiring validation, development of plans and analysis criteria, execution and final analysis and acceptance
• Help to create production schedules and allocate machine and labour resources including material Planning and fulfilment activities including waste streams
• Work with quality complaints, investigating both corrective and preventative action
• Supporting both compliance and Environmental, Health & Safety within the facility
• Assist in the development and maintenance of standard operating procedures and ensure adherence to them - Writing batch records, Work instructions, equipment SOP's
• Support and record preventative maintenance program for plant, tooling & machinery
GEHC Quality Objectives:
• Comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Complete all planned Quality & Compliance training within the defined deadlines
• Identify and report any quality or compliance concerns and take immediate corrective action as required
• Knowledge and understanding of production process Work Instructions and operates within them to ensure that a device conforms to its specifications
• Ensures the creation of accurate, complete and timely records
Going forward as the facility is validated The Production Engineer will assist in management of operators and technicians to ensure the team that fully utilizes resources to meet the scheduled activities of the Manufacturing Group. They will contribute to the supervision of daily shift activities in their assigned functional areas and work with team members to cultivate a winning manufacturing attitude and creative work environment.
This is a unique opportunity for an individual keen to take on a challenge and evolving the role to take on new opportunities as the facility, processes and technology develops. They will experience first-hand the rewards of working in a high tech, fast pace, environment where they have the opportunity to have input into the process taking cutting edge research to commercial products.
Qualifications and Requirements:
• Degree or equivalent in Mechanical, Electrical, Industrial Engineering or related technical degree or some experience in production, or engineering
• Strong written and verbal communication skills
• A degree of manual handling is required for this role
• Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website http://www.ukba.homeoffice.gov.uk/visas-immigration/working
• Degree or equivalent in Mechanical, Electrical, Industrial Engineering or related technical degree and some years of experience in production, or engineering
• Working in a chemical pilot plant
• Co-op or internship experience in Manufacturing Engineering
• 6-sigma DMAIC & DFSS certified
• Experienced developing tools and templates
• Demonstrated experience owning production processes / growing capability in yield and quality
• Operating inventory control systems e.g. Oracle
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