This position is accountable for leading the engineering team in achieving industry leading performance and creating a continuous improvement culture focused on driving/delivering improvements in safety, quality, process reliability, customer experience, and cost. Reporting into this position is the Engineering Process Manger, Facilities Manager, Tooling Manager, and Engineer Project Managers. In addition to these direct reports, this position is accountable for the following key site systems: Capital Budget/Management, New Product/Process Turnover to Operations, Equipment & Facility Standards/Qualifications, Process Management/Equipment Standardization, and Tooling Management. This position will collaborate cross functionally and with all levels in the organization to deliver overall site goals, implement improved systems/processes/equipment, and develop site capability to support growth.
ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING (OTHER DUTIES MAY BE ASSIGNED):
- Develops and presents engineering (process/equipment/tooling) options to meet customer requirement. Participates with BD to assist customers in defining requirements and develops time-bounded project plans to assure timely execution.
- Monitors, tracks, and reports key metrics (safety, quality, downtime, throughput, spending). Prioritize and guide engineering resources to identify and manage process/equipment improvements that optimize quality, service, reliability, and cost (labor and materials).
- Provides technical support to Operations as needed to minimize equipment downtime and improve process reliability.
- Identifies and manages technical staffing to adequately resource/support projects and new products launches. This could include working with engineering contractors and general contractors as needed.
- Leads development and management of capital plans for the site. Directly manages capital projects for facility and production equipment to assure production is in a position to meet business and regulatory requirements. Monitors actual spend v. budget to assure capital projects are completed on-time and within budget.
- Leads the specification and selection of manufacturing equipment/utility equipment and contracts based on competitive bids.
- Develops and maintains engineering equipment and process standards.
- Develops and leads equipment/process transfer process to Operations which collaboratively defines key success criteria and assures they are met prior to transferring ownership to Operations.
- Collaborates with the Training Manager to develop and provide technical training for all new equipment and processes.
- Maintains and continuously improves the site/facility to meet all regulatory requirements, key customer needs, and support internal department requirements.
- Prepares monthly reports to management detailing the status of open projects that support the capacity, regulatory and process improvement requirements of the plant. Visually communicate information regularly with all employees.
- Collaborates with Quality and Planning to schedule and qualify project work.
- Manages tooling for the site to include: design, ordering, inventorying, and verification.
- Utilize and promote Operational Excellence methodology to deliver objectives and develop talent. Utilizes formal project management tools to deliver and communicate all Engineering/Facility projects.
- Develops and staffs Engineering team to assure necessary talent to meet business needs now and for the future.
EDUCATION AND/OR EXPERIENCE:
BS Degree in engineering, 10+ years in manufacturing engineering.
High level of packaging knowledge
High level of facilities knowledge
Proficient project management skills
Good communication skills
Knowledge of cGMP facilities
Strong leadership skills
Technical transfer methodology
Specific and varied process technology knowledge
FDA/MHRA standards and audit
Operational experience as functional lead in major plant
Mathematical and reasoning ability
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to work effectively under extreme pressure to meet deadlines.
Creative thinker with sound business judgment. Good negotiation and reasoning skills.
Excellent written and verbal communications skills. Ability to easily learn and retain technical information.
Well-honed problem solving skills, including innovative and creative solutions.
Well organized with ability to handle multiple activities simultaneously.