A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Initiate, propose and implement optimization projects to reduce quality incidents, manufacturing costs, cycle times and/or increase product yield. Develop project justification and capital project proposal when required. You will work with Production, Maintenance and QA to ensure existing manufacturing processes remain in control. Develop process monitoring metrics to maintain cGMP compliance of manufacturing processes.
Manage complex projects using a designed project model to develop necessary milestones and deliver success including adherence to required time, quality and budget restrictions
Apply engineering and process innovations to reduce ergonomic stress to operators.
Develop and update process specifications for new processes and equipment. Manage transfer of manufacturing processes from other sites to Irvine.
Develop required SOPs for new processes and equipment. Revise SOPs for existing processes as needed. Manage change control for processes as required.
Coordinate transfer of process and equipment information with Validation.
Lead process trouble shooting efforts and corrective action implementation. Assist Maintenance department in specific trouble shooting of process equipment and controls.
Generate data that supports investigations for both internal and external customers.
Write protocols and report results of studies conducted, prepare literature for Marketing publication when applicable
Who you are:
- Degree in Mechanical, Electrical, Automation or Chemical Engineering with related experience or equivalent combination of education and experience.
- Significant cGMP manufacturing experience in the biotechnology or pharmaceutical industry including Project management experience and including the management of project budgets, scope and schedules.
- Extensive hands-on experience with process equipment.
- Extensive component selection and Process control systems/software experience.
- Experience of processing plant design/commissioning/validation.
- Proven ability to lead and participate as part of a team.
- Extensive knowledge of Facility utilities such as WFI, CCA, HVAC, pure steam systems, and Nitrogen
- Sound knowledge of structured project management methodologies – preferably with formal project management accreditation.
- Effective communication, influencing and decision-making skills at all levels
- Excellent and proven team building and team motivational skills
- Strong organising and time management skills with the ability to prioritize tasks.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com