Applications Engineering Manager (Bilingual Spanish/English)

ATS Scientific Products is searching for an Applications Engineering Manager (Bilingual Spanish/English) to join the team!

The Applications Engineering Manager will work closely with Sales, Systems Engineering, Operations, Technical Director and multi-disciplines Engineering functions, both locally and at sister company sites, to develop solutions meeting customer and industry requirements.  Manages the applications engineers based in two teams, locally in Warminster, and in Mataró, Spain – just outside Barcelona, to deliver detailed project proposals for approximately 100 projects annually, with project value ranging between $1m and $10m. 

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.
• Plans and directs applications engineering resources and aligns their activities with sales requirements
• 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

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• 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
• Experience in the application of configure-to-order and engineer-to-order
• 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 ERP systems
• Has the ability to energize and motivate people and to effectively communicate with all levels of the organization
• Has led organizations with a high level of integrity and accountability
• Excellent oral and written communication skills
• Effective human relations and negotiation skills
• Strong organization and project management skills
• Strong focus on accuracy and detail, with good questioning skills
• Able to think ahead and plan over a one-to-two-year time span
• Able to organize and manage multiple priorities and functional disciplines

EDUCATION:

• Bachelor’s degree in an engineering discipline, plus 5 years of experience with capital equipment, pharmaceutical equipment manufacturing, or chemical engineering; and 3+ years of experience managing and developing people, preferably in the pharmaceutical/ project-related equipment industry
• Experience and affiliation engineering and industry professional bodies is desired.

PHYSICAL DEMANDS:

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.

WORK ENVIRONMENT:

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.
• Some shop areas may be designate hard hat zones. 

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All managers are responsible for creating a positive safety culture and maintaining a safe and healthy workplace. It is the responsibility of each manager to ensure that employees receive regular training regarding health, safety and environmental matters.  Each manager is also accountable to ensure that HSE matters are addressed in a timely manner and that compliance with both legislative and corporate requirements are maintained.

Manager responsibilities for Health, Safety and Environment include:

• Demonstrate leadership in Health, Safety and Environment compliance
• Hold team members accountable for health, safety and environmental compliance as part of the annual performance review process
• Ensure that the requirements of the health, safety and environment management system are implemented and maintained
• Carry out hazard assessments, inspections, and audits as required by legislative framework and/or corporate requirements
• Ensure that training is provided to all departmental employees are per established training matrix
• Implement appropriate corrective measures for unsafe conditions and unsafe acts
• Ensure that appropriate equipment, materials and protective devices are provided and maintained in safe condition
• Provide information, instruction and supervision to employees 
• Take every precaution reasonable in the circumstances for the protection of employees