SP Industries is seeking an Engineering Manager to optimize designs and manufacturing methods for the safe production of high-quality equipment at the lowest possible cost. The Engineering Manager will initiate, develop, and implement innovative and cost effective designs for systems, sub-systems, and components of technologically sophisticated manual and automated vial washing, sterilization, filling, capping, and vial and tray loading and handling equipment used in the pharmaceutical industry.
This individual will be responsible for the quotation of new project opportunities through design, build, validation, and production release. The Engineering Manager will use their knowledge of product design, mechanical, electrical, and controls engineering, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards to evaluate and improve equipment designs and manufacturing methods. They will work closely with Project Management, Sales, Operations, and multi-discipline engineering functions to develop and implement new equipment designs and production processes.
The Engineering Manager will analyze and plan work force utilization, space requirements and workflows, and the layout of equipment and working space for maximum efficiency. They will confer with planning and design staff to ensure efficient production methods. They will estimate production times, staffing requirements, and related costs to provide information for management decisions. They will confer with engineering and other staff regarding manufacturing capabilities, production schedules, and other considerations to optimize production processes and apply statistical techniques to estimate future manufacturing requirements and potential opportunities.
The Engineering Manager is responsible for all engineering project costs, maintaining schedules, and the effective management of the engineering group. They are also responsible for adherence to quality control programs and the generation and maintenance of the required quality control documents.
Essential Duties And Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Plan and direct project-specific Engineering resources and blend and align activities with those internal resources of Engineering, Operations, Sales, Customer Service, and Quality according to the project requirements.
- Handle multiple projects and assignments for concurrent flow through engineering and production.
- Participate in the formulation of new equipment Performance Requirements and their translation into Design Specifications and equipment concepts.
- Interpret drawings, schematics and technical specifications.
- Interface with customers and the Sales team on technical matters involving equipment specifications and functions.
- Oversee all stages of manufacturing development of new equipment: Initial quotes, design iterations, build, validation and approval, and release to production of layouts, parts drawings, specifications, and Bills of Material.
- Develop detailed project schedules and budgets. Responsible for project execution: Cost, quality, product performance and timetable. Prepare periodic status reports for Leadership.
- Establish requirements and oversee negotiations for contract design work.
- Research available technologies with the objective of improving equipment quality, reducing cost or increasing employee safety. Develop plans to evaluate, implement, and audit the efficacy of technology improvement projects.
- Stay abreast of industry standards and regulatory requirements through competitive analysis, trade publications, and participation in outside organizations.
- Drive the review and approval of new equipment concepts and insure they are designed and tested to meet applicable functional and regulatory requirements. Maintain a working knowledge of all specifications and procedures required for the in-house and field-testing of Company products.
- Confer with engineering, technical, manufacturing, and service personnel as well as with customers to resolve problems of intent, accuracy, or feasibility of systems process functions related to equipment development.
- Direct activities to ensure that manufacturing, construction, installation, and operational testing conform to functional specifications and customer requirements.
Qualifications: Education, Experience, Skills, and Certifications
To perform this job successfully, an individual should possess the minimum qualifications cited.
Education, Experience, and Work Skills
- Bachelor's degree in engineering, MBA preferred,
- 8+ years of experience with manufacturing pharmaceutical or other capital equipment, or pharmaceutical or chemical engineering project management.
- 5+ years of experience managing and developing personnel in a project-related equipment industry, pharmaceutical or chemical preferred.
- Familiarity with aseptic processing and sterilization processes in the pharmaceutical industry is a plus.
- Possess a working knowledge of modern design validation tools, techniques and methodologies such as FEA, DFMA and DFSS.
- Must have experience engineering within a Quality Management System registered to ISO standards, to ISO 9001:2008 standard preferred.
- Lean, Six Sigma, TPS, or DMAIC experience.
- Proven track record of creating, implementing, or sustaining a lean operation.
- Experienced in developing, implementing and improving key performance indicators through strong data analysis and continuous improvement.
- Demonstrated leadership skills and ability to drive change in a fast-paced work environment.
- Demonstrated leadership with a high level of integrity and accountability.
- Able to maintain a high activity level while managing multiple priorities, functional disciplines, and projects. Must be extremely well organized with excellent project skills.
- Must have excellent oral and written communication skills, able to inform and motivate people at all levels of the organization as well as communicate effectively with customers, vendors, and others.
- Must have effective human relations and negotiation skills.
- Good problem analysis and resolution skills at both strategic and tactical levels.
- Able to use business cases and financial analysis to assess engineering and manufacturing decisions and their profit and loss implications.
- Able to analyze and plan ahead over a 1-2 year time span.
- Proficient in the use of the Microsoft Office Suite including Word, Excel, Outlook, Access, and MS Project.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The employee is regularly required to talk and listen.
- The employee is regularly required to use color vision and work with computerized data.
- The employee is regularly required to stand, walk, and sit.
- The employee is occasionally required to lift up to 20 pounds.
- The employee is regularly required to use normal office tools, equipment and PC's.
The work environment characteristics described here are typical of those an employee might encounter while performing the essential functions of this job.
- Work is normally performed in both the office and the shop.
- The office environment is an interior office with air conditioning.
- The shop contains mobile equipment, machinery, and high voltages.
- The shop noise level is variable and may require hearing protection in some areas.
- The shop is heated when required but many areas are not air conditioned.
- Some shop processes use high voltage arcs or concentrated magnetic fields.
- The shop contains open flames and caustic chemicals.