Accountable for leading and providing guidance/direction, as a subject matter expert, in the prioritization of the site improvement projects and for the development and implementation of continuous improvement solutions. Must comply with all Security Guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
1. Leads and provides guidance in the identification and implementation of strategic site improvement projects.
2. Ensures effective asset management to manufacturing and business processes and process flows applying Lean Manufacturing, Six Sigma, theory of constraints and other waste and variability-reduction principles.
3. Develops and manages site OpEx based tools and training programs. Standardizes and harmonizes Operational Excellence Project Management process including systems sustainability, Leader Standard Work, and coaching.
4. Manages the value creation and buy-in at all levels of the organization driving company’s major Lean Six Sigma based transformation programs, projects, and foundational systems. (Management, Technical and People Systems).
5. Reviews and analyzes data sources (SAP reports, department-level spreadsheets, and other data sources) for quality, efficiency, yield, and other information.
6. Provide notification if results are changing to a significant degree. Provide guidance and training to area process owners in the development and execution of their improvement plans.
7. Contributes in transforming the site culture of excellence through an effective leadership, communication with different stakeholders in the organization.
8. Participates in the decision-making process surrounding the design, procurement, and implementation of new equipment, facilities, and manufacturing processes.
9. Ensures process efficiencies in the product commercialization and launches process.
10. Manages OpEx department’s metrics related to safety, quality, customer service, productivity, and financial effectiveness and develops efficient and effective means of collecting and communicating these metrics for the use of Production and other departments.
11. Ensures link between Production and Finance to aid in tying together the manufacturing processes and the financial results obtained from execution of those processes.
12. Identify areas of opportunities and /or recommends initiatives to correct or improve financial outcome.
- Accountable for continuous improvement key projects implementation aligned with business and site priorities.
- Proactively identifies key issues and promote decisions, anticipates problems develop alternatives, and review execution against targets at all levels of the organization.
- Applies root cause analysis, problem solving & project management approaches in the Decision Making Process.
- Evaluates diverse alternatives supported by graphical-tabular-statistical tools to recommends the best alternative.
- Identifies and anticipates problems or constraints; and recommends an on time course of action.
- The incumbent is expected to make different recommendations/decisions consistent with priorities, delivering results, driving for continuous improvement demonstrating leadership skills in a fast paced and “ever changing” environment.
- Actively measuring sustainability of systems and tools. Provide Coaching on Leaders Standard Work across site.
- Decisions related to personnel performance, recruitment, and disciplinary actions based on Company policies
Knowledge and Skill:
- Bachelor’s Degree in Natural Sciences or Mechanical, Electrical, Industrial or Chemical Engineering.
- Seven (7) years experience managing continuous improvement projects in a pharmaceutical, manufacturing or medical devices environment assuring implementation of Company objectives and strategies, tactics, and plans
- Significant knowledge of relevant governmental regulations, cGMP’s and pharmaceutical guidelines.
- Three (3) years experience working with and leading a diverse, cross-functional team for projects and initiatives or supervising groups of employees where continuous improvement projects were involved.
- In-depth knowledge of a combination of Lean Manufacturing, Theory of Constraints and Six Sigma. Proven Statistical knowledge and practice.
- Black Belt or Lean Master certification and proven experience in effective Lean/Belt people coaching
- Ability to leverage both internal and external resources from various levels
- Knowledge in the use of Microsoft Office applications and SAP
- Excellent interpersonal skills, team work oriented and able to work under pressure in a fast paced and ever changing environment
- Self-starter with good organizing and planning skills, strong leadership
- Strong communications skills: fully bilingual Spanish/English both written and verbal are required
- Experience in writing executive summary type presentations to senior management and technically detailed presentations to specialized technical groups such as Manufacturing Technology, Engineering and QC/QA
- Significant abilities and aptitude for analyzing data detecting inconsistencies, determining relative importance and referring to the data analysis tools such as process capabilities, hypothesis testing, DOE, regression, etc.
- Ability to review SOP’s and operating instructions
- Ability to establish and maintain excellent working relationship with a variety of internal and external customers
- Broad knowledge of relevant governmental regulations, cGMP’s and guidelines
- Excellent presentation skills and experience at Senior management level
- Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary