UK - Manufacturing Process Engineer - Normal
A globally renowned pharmaceutical company is seeking to recruit a Manufacturing Process Engineer to their office in the UK. The organisation works across a range of industries, from medical devices to pharmaceutical and consumer goods, and operates in over 60 countries. This position offers an exciting opportunity to work with a prestigious and historic pharmaceutical establishment.
- Process review and optimisation of specified process area/s.
- To input into new product development, to ensure timely introduction into production and that they are operationally cost effective.
- Initiation / completion of deviations, remedial actions, CAPAs and other quality system documentation.
- Undertake pFMEA reviews for the areas.
- Adhere to the Change Control and Design Control requirements.
- Control and direct manufacturing validation effort for existing and new processes.
- Active member of multifunctional process and production improvement team.
- Application of world class manufacturing tools and techniques (Lean, ME2) within aligned process areas. * Problem identification and resolution to root cause.
- Responsible for Waste reduction in area
- Actively drives process improvement projects to achieve OEE targets for area of responsibility
- Leadership and coordination of onsite Process Excellence initiatives and activities including certification, re-certification and promotion of PE awareness on site.
- Input into machinery purchases, investigating new technologies for existing processes.
- To follow and promote Company, HS&E and Quality standards to enable the site to achieve and maintain excellent results
- To liaise with outside contractors whilst leading projects from conception to commissioning and handover.
- To ensure that processes are robust and as efficient and effective as possible.
- Perform other duties as assigned
- Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations (FDA / GMP / BSI / ISO, etc.).
- Responsible for ensuring company compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Accountable for HSE compliance for their area of responsibility.
Skills and Requirements:
- Technical degree in related discipline (Engineering/Science/Chemical) preferred.
- Minimum HND in related discipline.
- Minimum of two years of experience within same or similar industry.
- Ideally certified to Green Belt standard Experience.
- Minimum 2 years of experience in engineering/process engineering preferably in a medical devices/pharmaceutical environment.
- Proven track record of installing/validating new equipment and processes in a highly regulated environment.
- Experience in Lean Manufacturing Initiatives to deliver business benefit.
- Able to demonstrate process, equipment improvements and waste reduction savings.
- Lean Manufacturing application (Lean Green Belt).
- Use of KPIs to improve business performance.
- Lean Black Belt.
- Previous experience in Production/Manufacturing environment essential.
- Knowledge of IQ, OQ, PQ.
- Ability to carry out structured problem solving, and Credo based decision making skills.
- Understands and applies HR policies and systems.
- Knowledge of CMW organization and products.
- Knowledge of PEx , ME2 and Lean principles.
- Knowledge of pFMEAs and BS EN ISO 14971: 2012.
- Knowledge of Business Continuity Process and capable to lead fault finding processes.
- Knowledge of Quality Management Systems.
- Knowledge of Health, Safety, and Environment system requirements.
- Appreciation of budget planning and control.
- Understanding of the CapEx process.
- Must have an understanding of budget control & project management.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact James Wilson at +44 203 762 2703 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.