- Oversees progress and timeliness of projects.
- Reviews project reports to ensure projects are on schedule and within budget.
- Provides leadership for employees through effective communication, coaching, training, and development.
- Provides leadership for problem resolution to facilitate fast improvements and improved working relationships.
- Develops and implements a culture of continuous improvement through self-directed work teams.
- Leads design engineering related to new product development and product & systems enhancements.
- Develops and oversees machine and process validation programs, ensuring validation timelines are met.
- Work with production to be aware of production schedule and needs, ensuring manufacturing engineering is working as a team with production to achieve goals.
- Prepare and manage capital projects including identifying scope, cost, milestones, etc.
- Establishes, prepares, implements, revises, and maintains policies and procedures related to engineering and facilities.
- Oversees scope development, estimating and schedule commitments as part of building capex project proposals and administers and oversees Master site planning efforts at sites as required
- Drives site projects and project teams as needed, works with sites to problem solve and clear roadblocks during execution, and coordinates steerco's and governance metrics for sites in the network
- Support operating sites in the following areas: Capex planning, Technical reviews on projects
- Review, analysis and recommendations on new technologies and/or service providers
- Operational review on challenging site problems (i.e. Contaminations, equipment robustness etc.)
- Plans and coordinates the work of engineering staff.
- Oversees engineering staff and ensures that they meet goals and objectives.
- Recruits additional engineering staff as needed.
- Conducts performance evaluations that are timely and constructive.
- Provides training and mentoring as needed.
- Excellent written and verbal communication skills.
- Excellent managerial and supervisory skills.
- Excellent analytical and problem-solving skills.
- Extensive technical knowledge of engineering and product development.
- Excellent financial skills and ability to analyze financial data.
- Proficient in Microsoft Office Suite or similar software.
- Bachelor's degree in Engineering or related field
- Min. 15 years of Engineering experience.
- Min. 5 years of Engineering/Maintenance Management in the Med Device/Pharma Industry
- Excellent people, communication and management skills to create a team environment
- Good leadership skills to motivate plant personnel and gain their respect
- Solid knowledge base and experience in engineering/construction project controls and project execution and ability/experience functioning globally within a diverse team
- Ability to produce and present clear, concise, and professionally written communications and presentations.
- PE license or Master's degree in Engineering or an MBA
- Knowledge of Sterile Aseptic Filling Operations
- Startup or Small company experience working in a dynamic and hands-on role.
- Six Sigma, Lean Manufacturing, continuous improvement, etc.
- Contract Manufacturing experience working closely with customers and clients
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