Engineering Manager, (Pharmaceutical Capital Equip) - We're growing!!
- Responsible for optimizing design methods for the safe production of high-quality equipment at the lowest possible costs beginning with quotation of new project opportunities through design / build / validation / production release of Pilot, Lab, Research Freeze Dryers through to Production Freeze Dryers, and all other ancillary equipment. This individual will work closely with Project Management, Sales, Operations, and multi-discipline Engineering functions to development and commercialize new equipment and processes: 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.
- Analyzes and plans work force utilization, space requirements and workflow, and the design layout of equipment and work space 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.
- 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.
- This position 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.
- Plans and directs project-specific Engineering resources and blends/aligns their activities with those internal resources of Engineering, Operations, Sales/Customer Service, and Quality according to the Project Management.
- Participates in the formulation of new equipment Performance Requirements and the translation into Design Specifications and equipment concepts
- Interfaces with customers and the Sales team on technical matters relating to new and refurbished equipment
- Interprets drawings, schematics and technical specifications
- Responsible for all stages of manufacturing development of new equipment: initial quotes, design, build, approval and validation of equipment
- Knowledgeable of modern design validation tools/techniques and methodologies, such as FEA, DFMA and DFSS
- Oversees 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; prepares periodic status reports for Leadership
- Develops detailed project schedules and budgets
- Leads negotiation responsibilities for contract design work. Understands the business case and has an appreciation of financial/analytical issues and profit and loss implications
- Researches available technologies with the objective of improving equipment quality, reducing cost or increasing employee safety; develops sensible plans to evaluate, implement and then to audit the efficacy of completed technology improvement projects
- Keeps abreast of industry standards and regulatory requirements through competitive analysis, trade publications, and participation in outside organizations
- Determines the required design parameters for testing of products and the preparation of test packages
- Drives the review/approval of new equipment concepts and insures they are designed and tested to meet applicable functional and regulatory requirements. Maintains a working knowledge of all specifications and procedures required for the in-house and field-testing of Company products
- Confers with engineering, technical, and service personnel as well as with customers to resolve problems of intent, inaccuracy, or feasibility of systems process functions as related to program development
- Reviews results of computer runs with interested personnel to determine necessity for modifications or reruns
- Designs and advises manufacturing personnel in fabrication of control or power apparatus and equipment, and determines methods, procedures, and conditions for testing products
- Develops applications of controls, instruments, and systems for new commercial and/or industrial, freeze drying or related pharmaceutical process equipment
- The incumbent provides technical and administrative direction to CAD operator/designs within his reporting structure
- Interfaces with both design and project engineers to provide design/drafting resources to meet the project needs
- Directs activities to ensure that manufacturing, construction, installation, and operational testing conform to functional specifications and customer requirements
- Uses computer assisted engineering and design software and equipment to perform engineering tasks
- Interfaces at all levels with management, engineering associates and customers to resolve all related control issues in process equipment function
- Handles multiple projects and assignments for concurrent flow through engineering and production
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required:
- Knowledge of all power wiring and control components related to freeze dryers
- Is able to maintain a high activity level managing and prioritizing numerous projects
- Knowledge of aseptic processing and sterilization processes in the pharmaceutical industry
- Is able to interface well with colleagues and customers to access control requirements and functional operation
- Extremely well organized with good project skills
- Proficiency in the use of the Microsoft Office Suite including Word, Excel, Outlook, Access MS Project
- Has the ability to energize and motivate people and to effectively communicate with all levels of the organization
- Demonstrated leadership skills and ability to drive change in a fast-paced work environment
- Proven track record of creating, implementing and/or sustaining a lean operation
- Has led their organizations 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
EDUCATION and/or EXPERIENCE
- Bachelor's degree in engineering, MBA preferred, plus 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 the pharmaceutical/ project-related equipment industry
- Experience and affiliation with Mechanical Engineering, Refrigeration, Vacuum, Pharmaceutical, Heat Transfer or Engineering societies and/or groups is encouraged and recognized
- Lean, Six Sigma, TPS, or DMAIC experience is suggested
- Demonstrated motivational and leadership skills
- Excellent oral and written communication skills
- Effective problem solving skills
- Effective human relations and negotiation skills
- Strong organization and project management skills
- ISO 9001expereince
- Ability to think ahead and plan over a 1-2 year time span
- Ability to organize and manage multiple priorities and functional disciplines
- Problem analysis and problem resolution at both a strategic and functional level
SP Scientific, Inc. is a privately held manufacturer of laboratory and process equipment serving the pharmaceutical, biotechnology, scientific, educational, industrial, and OEM markets. It is comprised of leading well known brands representing over 250 combined years of experience, quality and innovation. SP Industries is a global supplier committed to providing the best products and services available to its customers. We offer a world-wide sales and service network with full product support including training and technical assistance.
Tue, 28 Mar 2017 12:28:00 PDT