Reporting to the Materials Engineering Lead the Senior Materials Engineer will provide a lead role in the project & validation engineering of Materials Development projects.
The job holder will lead the technological improvements and product transfers in conjunction with local Quality, Engineering, Operations and DePuy R&D personnel ensuring timely communication to all stake holders to effect successful project completion. They will also be able to successfully move between validation, project and process functions effectively. This role involves providing technical leadership working with a cross functional team to develop and validate advanced manufacturing systems for the implementation of leading edge technologies and innovative processes to build excellence in equipment and computer system and process validation.
MAIN DUTIES & RESPONSIBILITIES:
- Consolidation and validation of Project Plans and deliverables
- Manage communication and work commitments with teams' external to the core team
- Facilitate technical problem resolution through the application of best practice tools such as 8-D, DMAIC, etc
- Define process outputs, transfer functions, process inputs. Understand sources of variation and inference spaces. Implement process characterization and input control to attain true process validation
- Understand Validation, Process and Project engineering related to job function/projects and lead the Engineering Team through these areas effectively
- Characterize product and process, including identification of CQA's and CPP's, performing DOE's to define relationship models, documenting design space, creation of control plan
- Define Material Characterization using advanced analytical techniques. Partner with key functions to understand test analysis and next specs
- Facilitate process FMEA and ensure action follow-up and revisions as required. Utilize other QA risk analysis techniques as required to minimize potential risk during development/implementation activity.
- Ensure that all changes and activities conform to local and corporate, statutory, legislative and regulatory requirements for GMP, HSE and Quality
- Ensure project changes are tracked and actioned appropriately. Implement Engineering Change Control throughout Design/Commissioning and Site Change Control during validation/production.
- Drive Validation/Verification strategies, authoring Master Validation Plans
- Ensure correct use of statistical QA methods for the project
- Create and maintain an environment of innovative continuous improvement, focusing on quality, cost reduction, process development and supply
- Co-ordination of effective resourcing of projects and the management of individual performances to defined objectives
- Lead Project team when necessary and required as delegate of Direct
- Support testing & sampling when necessary and required to ensure successfully project tasks completion
- Communicate with key stakeholders when required
- Experience in a Technical Environment - Experience in the areas of polymers, coatings, biomaterials, Material Characterization (chemical/physical) and in advanced analytical techniques
- Experience in Project Management
- Track record in team leadership including strong mentoring & coaching skills demonstrated in a business environment
- Strong communication, reporting and presentation skills
- Previously worked with rigorous project management methodology
- Familiar and experienced in problem solving methodologies
- Demonstrated record of strategic thinking and tactical responsiveness
- Continuous Improvement Focus
- Proven knowledge and understanding of medical device/pharmaceutical regulated industry including FDA and GMP requirements
- Working knowledge of Quality Management Standards
- Working Knowledge of Equipment and Process Validation
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
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