Description
Technical specialist for the Liquids & Final Pack Value Stream.
Duties & Responsibilities
- 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, CAPA's 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.
Education and Experience
- Technical degree in related discipline (Engineering/Science/Chemical)
- Experience in engineering/process engineering 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
- Ability to deliver projects on time and to budget.
- Able to demonstrate process, equipment improvements and waste reduction savings.
- Continuous Improvement orientation
- Previous experience in Production/Manufacturing environment essential.
- Knowledge of IQ,OQ, PQ
- Knowledge of CMW organization and products
- Knowledge of PEx, ME2 and Lean principles
- Knowledge of pFMEAs and BS EN ISO 14971: 2012
- Knowledge of Quality Management Systems
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
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