Provide process expertise along with key skills relating to validation, process optimization and problem solving. Support and deliver projects from the Project Portfolio and work closely with all teams to ensure that CI is embedded at every level within the organization and that all deliverables are constantly improved. Embrace and drive ConvaTec's core mission, values and priorities. Managing multiple projects, which will vary depending on the complexity of the project/change. Your key duties and responsibilities:
- Perform IQ, OQ, PQ validation
- Update and maintain change control systems and associated documentation
- Identify and deliver cost savings
- Adhere to legal, corporate and site legislation, and procedures
- Compliance with GMP requirements and uphold these standards
- Compliance with EHS requirements and uphold these standards
- Develop and maintain detailed project plans, clearly identifying and sequencing all activities required for successful and timely project delivery.
- Seek and deliver CI opportunities across the site Managing complex projects, adhering to timelines and budgets.
- Demonstrated experience in Manufacturing CI support role
- Understanding of Risk management for Medical Devices.
- Demonstrated expertise in problem solving centered around CAPA's and NC's.
- Experience working within a lean manufacturing environment.
- Must have in-depth working knowledge of all processes and equipment within focus factory.
- Understand the implications and requirements of external regulations, particularly GAMP5, FDA & MHRA, EHS and manufacturing legislation.
- Demonstrated project and time management skills, including a track record of creating plans and meeting deadlines.
- Proven ability to balance multiple, competing priorities.
- Demonstrated interpersonal skills and a good team player, proactive and flexible approach.
Qualifications/Education:
- Degree, or equivalent in an Engineering Discipline
- Six Sigma Green Belt, or demonstrates a similar approach to problem solving
- PC Skills including SAP, Word, Excel, PowerPoint, MS Project, CAD
- Trained in IQ, OQ, PQ validation principles
- Strong Working Knowledge of Problem-solving tools.
- Kaizen lead trained.
- Prince 2 Practitioner or a Project Management Professional (PMP) qualification desired.
Continuous Improvement Process Engineer in Shotton employer: ConvaTec Inc
Convatec is an exceptional employer that fosters a collaborative and dynamic work culture, particularly for the Wound Care Territory Sales Leader role in the vibrant regions of South West London, Surrey, and Sussex. With a strong commitment to employee development, we offer comprehensive training and growth opportunities, ensuring our team members thrive in their careers while making a meaningful impact in the healthcare sector.
