Director of Engineering, Equipment - SP Scientific: FTS, Hull, VirTis SP Industries
Location: Warminster, PA
Schedule: Monday - Friday, 8:00 AM to 5:00 PM
FLSA Status: Salaried Exempt
SP Industries is seeking a Director of Engineering, Equipment, who will be responsible for optimizing manufacturing and design methods for the safe production of high-quality equipment at the lowest possible cost. Responsibility begins with the quotation of new project opportunities through design, build, verification, and production release of Pilot, Lab, Research, and Production Freeze Dryers, and all other ancillary equipment. The Director will work closely with Project Management, Sales, Operations, and multi-discipline Engineering functions to develop and commercialize new equipment designs and manufacturing processes.
The Director of Engineering, Equipment, develops, evaluates, and improves manufacturing and design methods utilizing knowledge of product design, mechanical, electrical, and controls engineering, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards.
The Director analyzes and plans work force utilization, space requirements and workflow, and the design layout of equipment and workspace for maximum efficiency. Confers with planning and design staff concerning product design and fabrication to ensure efficient production methods. Estimates production times, staffing requirements, and related costs to provide information for management decisions. Confers with engineering, and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production processes. Applies statistical methods to estimate future manufacturing requirements and potential.
The Director is responsible for all engineering project costs, maintaining schedules, and the effective management of the engineering group. Also included is the responsibility for ASME pressure vessel design and quality control programs consisting of ASME and National Board Registration, compliance, execution and the generation and maintenance of the documented quality control program for same.
The Director of Engineering, Equipment, initiates, develops and implements innovative and cost effective designs for systems, sub-systems and components of technologically complex lyophilizers and other equipment used in the pharmaceutical industry.
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 align their activities with those of Supply Chain, Operations, Sales and Customer Service, and Quality personnel according to the Project Management requirements.
Participate in the formulation of new equipment Performance Requirements and their translation into Design Specifications and equipment concepts.
Drive the review and approval of new equipment concepts and insure they are designed and tested to meet applicable functional and regulatory requirements.
Direct negotiations for contract design work.
Responsible for all stages of manufacturing development of new equipment: Initial quotes, design, build, approval, and verification of equipment.
Research available technologies with the objective of improving equipment quality, reducing cost or increasing employee safety; develop sensible plans to evaluate, implement and then to audit the efficacy of completed technology improvement projects.
Keep abreast of industry standards and regulatory requirements through competitive analysis, trade publications, and participation in outside organizations.
Determine the required design parameters for the testing of products and the preparation of test packages.
Develop applications of controls, instruments, and systems for new commercial freeze dryers or related pharmaceutical process equipment.
Design and advise manufacturing personnel in the fabrication of control or power apparatus and equipment, and determine methods, procedures, and conditions for testing products.
Interface with customers and the Sales team on technical matters relating to new and refurbished equipment.
Interpret drawings, schematics and technical specifications.
Oversee the creation and control of layouts, equipment drawings, specifications and bills of material according to SP requirements.
Responsible for project execution according to agreed cost, quality, product performance, and timetable requirements; prepare periodic status reports for Leadership.
Develop detailed project schedules and budgets.
Maintain a working knowledge of all specifications and procedures required for the in-house and field-testing of Company products.
Confer with engineering, technical, and service personnel as well as with customers to resolve issues of intent, accuracy, or feasibility of systems process functions related to controls program development.
Provide technical and administrative direction to CAD designers within the reporting structure.
Interface with both design and project engineers to provide design and drafting resources to meet the project needs.
Direct activities to ensure that manufacturing, construction, installation, and operational testing conform to functional specifications and customer requirements.
Use computer assisted engineering and design software and equipment to perform engineering tasks.
Interface at all levels with management, engineering associates and customers to resolve control issues and process equipment functions.
Review equipment test results with the appropriate personnel and determine the necessity for reruns or modifications to programming or hardware.
Handle multiple projects and assignments for concurrent flow through engineering and production.
Some travel may be required, both domestic and foreign.
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.
8-10 years of experience with capital equipment, pharmaceutical equipment manufacturing, or chemical engineering.
5-7 years of experience managing and developing people, preferably in a project-oriented industry such as capital equipment.
ISO 9001 experience.
Knowledge of modern design verification tools, techniques and methodologies such as FEA, DFMA and DFSS.
Knowledge of aseptic processing and sterilization processes in the pharmaceutical industry is preferred.
Knowledge of power wiring and control components related to freeze dryers is preferred.
Lean, Six Sigma, TPS, or DMAIC experience is preferred.
Able to make a business case with a financial analysis and a risk analysis with consideration of the profit and loss implications.
Demonstrated leadership skills and ability to drive change in a fast-paced work environment.
Demonstrated motivational and leadership skills.
Proven track record of creating, implementing or sustaining a lean operation.
Proven leadership with a high level of integrity and accountability.
Experience in developing, implementing and improving key performance indicator metrics through strong data analysis and continuous improvement.
Excellent oral and written communication skills.
Effective problem solving skills.
Effective human relations and negotiation skills.
Strong organizational skills.
Extremely well organized with good project management skills.
Able to maintain a high activity level managing and prioritizing numerous concurrent projects.
Able to interface well with colleagues and customers to assess control and functional operation requirements.
Able to energize and motivate people and to effectively communicate with all levels of the organization.
Proficiency in the use of the Microsoft Office Suite including Word, Excel, Outlook, Access, and MS Project.
Affiliation with Mechanical Engineering, Refrigeration, Vacuum, Pharmaceutical, Heat Transfer or Engineering societies and groups is encouraged and recognized.
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.
||935 Mearns Road |
Warminster, PA 18974