Manufacturing Engineer Manager - Pharmaceuticals 

Primary Functions

The Manufacturing Engineering Manager will be responsible for identification, development, and execution of projects necessary for manufacturing and process improvements geared towards company goals and objectives. This operations support role will be deemed successful by overall plant productivity, cost reduction projects, adherence to safety rules and on-time delivery of quality results. This includes identifying manufacturing needs, defining scope, measuring, and reporting progress on all active projects. Must also be a hands-on, proactive leader who works well in a constantly evolving FDA regulated manufacturing environment. Drives innovation in engineering & manufacturing processes through continuous process improvement capabilities with respect to efficiencies, capacities, costs, and productivities in all areas of manufacturing. Provides support for the production of existing products and provides new product integration support. The incumbent will coordinate the activities of the manufacturing engineers.

Duties and Responsibilities:

• Learn and understand all products, systems and manufacturing operations in all facilities.
• Provide technical expertise for manufacturability, product cost, workflow, quality & safety. Apply fundamental Lean principles and tools including waste elimination, daily management, problem solving, 6S visual management, standard work, and value stream mapping. Evaluate and resolve causes of manufacturing yield and quality problems.
• Leads and motivates Manufacturing Engineering team whose primary responsibility is to define, implement, and improve manufacturing processes. Consult, coach, develop and train team members to excel in continuous improvement tools.
• Arrange manufacturing engineering support to other departments as required.
• Work with Marketing, Packaging Engineers, Manufacturing, Maintenance, Supply Chain, and Product Development to develop and launch new products.
• Provide tactical support and project management for resource leveling of the Manufacturing Engineering team.
• Support and assist Engineering/R&D new product development/implementation projects.
• Assure that procedures and work instructions are correct, efficient and applicable.
• Maintain team project status and visibility; ensure open communication, flow defect tracking, and project scope.
• Serve as liaison between personnel on projects and the engineering department.
• Work with all departments and employees to coordinate improvement activities and encourage process ownership.
• Devise and establish new solutions to existing manufacturing problems
• Perform research, design and development of manufacturing processes, including production flow, assembly methods, and production equipment
• Identify, and lead continuous improvement processes and projects with a focus on improving safety, quality, productivity, cost reduction and employee engagement.
• Develop standards for each work center through time studies measuring utilization and efficiency.
• Justify equipment purchases and capital investments to management with rationale and supporting data, including cost benefit analysis.
• Perform other assigned duties as may be required in meeting company objectives.
• Communicate effectively with other departments within the organization and function within a team environment.

• Manage, lead and execute Lean, continuous improvement, work cell and equipment design that optimizes floor space plus other special projects.
• Lead cross functional teams to drive processing projects from conception to completion.
• Identify and prepare business cases for capital investments
• Prepare key performance indicators (KPI's) and continuous improvement projects.
• Perform other work-related duties as requested, directed or assigned by management.
• Regular attendance is required.

Knowledge, Skills and Abilities

• Knowledge of material handling, manufacturing equipment and processes, automated packaging and manual work centers.
• Knowledge of common manufacturing processes packaging and assembly line production.
• Ability to exercise Lean Manufacturing tools, such as SPC utilization, 6S, Value Stream Mapping, KPI's and Kanban.
• Demonstrated project management in a fast-paced environment with ability to re-prioritize as needed.
• Ability to act independently and make independent decision when needed.
• Strong sense of urgency.
• Ability to solve engineering problems and deal with a variety of concrete variables in situations where limited standardization may exist.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Education and Experience:

• Bachelor degree in Engineering, preferably Industrial, Manufacturing or Mechanical.
• Minimum of 2-4 years' experience as a Manufacturing Engineer in regulated industry.
• Minimum of 1-2 years' experience in a functional supervisory role utilizing project management.
• Minimum of 5 years' experience in a cGMP facility, including experience with Continuous Improvement and Project Management. Strong problem solving and applied statistics skills are required. Experience with FDA/FSMA processes and procedures including implementation and audits.
• Technical expertise & application experience in manufacturing-based applications. Experienced in root cause analysis techniques and failure mode and effect analysis.
• Certification in Lean manufacturing
• Six Sigma certification ' green/black belt
• Expert in CAD / SPC / Gantt Charts
• ERP experience is a plus, preferably design, testing, and implementation related to manufacturing processes
• Self-motivated worker with the ability to identify priorities and work independently.

Supervisory Responsibilities:

• Directly supervises a team of Manufacturing Engineer(s).
• Carries out supervisory responsibilities in accordance with the organization's policies and ethnics.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; working on manufacturing processes side by side with subordinates as required; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.