Applications Engineering Manager
hace 4 meses
**ATS Scientific Products **is searching for an **Applications Engineering Manager (Bilingual Spanish/English) **to join the team
**RESPONSIBILITIES**:
- Responsible for detailed review of customer requirements and development of solutions to meet the needs of the customer, maximizing use of standard and existing designs to minimize risk and in line with product development roadmap.
- Responsible for generation of consequent bid, costing and quotation packages and highlighting areas of risk, and potential future product / technology development by the Company.
- Role should develop a detailed understanding of design / build / qualification / production of aseptic primary packaging and finishing systems, and generate and optimize tools to help identify and monitor risks and opportunities affecting quality, cost and time in delivery of the customers project.
- Focus is also required to help move SP to the next level in engineering design and execution, implementing a configure to order mentality through team development and critical review, plus improving all areas of work using LEAN tools from the ATS Business Model.
- Responsible for collating all costing and producing bid packages to meet customers’ needs, in compliance with industry best practice and standards.
- Responsible of creating the library and classifying all layouts for standard machines and options
- Responsible of crating the library and classify all standard BOM and options
- Ownership of front end of sales process through bid, to successful confirmation of URS after receipt of order, and handover to project management and systems engineering.
- Owner of URS throughout duration of the project
Initiate project risk assessment covering safety, legal, commercial, engineering, manufacturing and service aspects.
Development of common practice, process and tools to help teams deliver quotes quickly and accurately
- Management and motivation of teams in two locations, including development of skills and cross training to enhance efficiency.
- Estimation of 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.
- Identification of innovative and cost-effective designs for systems, sub-systems and components of technologically complex equipment used in the pharmaceutical industry.
- Discernment to appropriately query Customer requests, escalate internally and ability to politely decline, when required.
- Maintains up-to-date knowledge of standards and regulations influencing aseptic packaging.
- 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.
- Owner to URS exceptions and clarifications process and to work to confirm changes to customer URS
- Knowledgeable of modern design validation tools/techniques and methodologies, such as FEA, DFMA and DFSS
- Leads negotiation for what is in / out of scope for design work and deliverables. 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, such as ISPE and PDA
- Determines the required design parameters for testing of products and the preparation of test packages
- 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
- Handles multiple projects and assignments for concurrent flow through engineering and production
**EXPERIENCE/ QUALIFICATIONS**:
- Business fluency in Spanish and English, verbal and written, is a requirement for this role. Fluency in the Catalan language is an advantage, but not a requirement.
- Knowledge and understanding of the following standards and regulations: FDA cGMP, ISPE GAMP5, ASME BPE, ISO 14644, GHS and EudraLex Vol 4 EU Annex 1
- Demonstrated leadership skills and ability to drive change in a fast-paced work environment
- Proficiency in the use of the Microsoft Office Suite including Word, Excel, Outlook, Project, PowerPoint, Visio
- Proficient with Draftsight, SolidWorks experience is beneficial, but not required
- Sound working knowledge of
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