Manufacturing Engineering Manager
3 weeks ago
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Job Summary
We are seeking a high-caliber Manufacturing Engineering Manager to lead the planning and completion of production and support area engineering projects. The successful candidate will be responsible for implementing and maintaining Facilities, Utilities and Equipment (FUE) supporting the worldwide manufacture of Biologics and Transfusion Instrument test kits to meet daily production schedules while enhancing productivity and product quality.
Key Responsibilities
- Provide leadership to engineering staff regarding project prioritization, engineering technical execution, Facilities, Utilities and Equipment (FUE) validation along with continuous improvement activities.
- Projects focused on Facilities, Utilities and Equipment (FUE) supporting all site Manufacturing areas including fermentation, biologics production, and automated fill/finish of instrument testing products.
- Implement and manage resource planning and project management tools.
- Collaborate with Engineering Department managers in selecting and scheduling engineering staff for Operations projects.
- Support continuing production, process development and new product introductions.
- Monitor and evaluate project and department progress and results.
- Participate in cross-functional teams.
- Review and approve protocol and written reports.
- Drive continuous improvement of engineering technical capabilities.
- Prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis.
- Coach, manage and develop technical staff.
- Develop, implement, train, and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, GMP, CBER and all other applicable agency regulations.
- Ensure a safe work environment consistent with OSHA requirements and Abbott Policies.
- Prepare departmental budgets and control expenditures to stay within spending limits.
- Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Requirements
- BS in Engineering
- 5 years engineering/leadership combined experience, with minimum 3 years of technical staff management experience and/or 3 years of project management experience involving direct coordination of cross-functional teams.
- 5 years prior experience in manufacturing support roles.
- Experience with validation / qualification of Facilities, Utilities and Equipment (FUE) including process equipment, automated equipment and related software systems.
- Experience with technical troubleshooting and support of both new and aging Facilities, Utilities and Equipment (FUE).
- Experience with Lean manufacturing, value stream mapping, and continuous improvement methodologies.
- Solid people management and communication skills.
- Base knowledge of GMP, ISO, CBER regulations.
- Demonstrated success in leading technology transfers of new equipment systems into site operations.
- Ability to work in a highly matrixed diverse business environment.
- Strong leadership skills, including the ability to set goals while providing positive and constructive feedback respectfully to build positive relationships and improve business results.
- Ability to work effectively within a team in a fast-paced changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multi-tasks, prioritizes and meets deadlines in timely manner.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable.
- Ability to travel approximately 10% or less, including internationally.
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