Project Engineer

SUMMARY

Represents Sharp's Engineering functions related to new business development projects and strategic Capital programs at all Sharp facilities and acts as the project lead for all Engineering functions deployed in support of new business projects and initiatives. Plans, directs, and coordinates activities involved with design, specifications, estimating, procurement and implementation of equipment, tooling and technology used to support new business programs. Responsible for supporting Account Executives while acting in the role of technical liaison for customers. Serves as the subject matter expert for Sharp and customer owned equipment.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following :

Drive the design and development of assembly and packaging projects as requested for all new product launches and processes.Includes; technical project management, identification of customer needs, conversion of customer needs to design requirements, process design and development, machine / equipment selection, machine / equipment qualification, and the implementation of machine / equipment in production environments.

Support the validation of packaging processes through the utilization of technical knowledge on machine / equipment parameters, capabilities, and final product design requirements and functional requirements.

Support divisional production operations as requested, by providing technical solutions to improve upon process inefficiencies and final product quality as well as provide any support for equipment repair / upgrades as required.

Support Account Executives in the effective communication of new product innovations and technical concepts and capabilities with Sharp's customers as part of the Company's new business strategy.

Support ongoing technical reviews of existing core / key machines / equipment and technologies available in the packaging market place.To include; provision of gap analysis for existing Sharp technologies and capabilities, provision of technical solutions to identified gaps in Sharp technologies and capabilities, and the design and development of plans to improve upon Sharp's technologies and capabilities to improve the fitness and competitiveness of Sharp within the healthcare contract packaging market.

Identify technical and process solutions to improve upon Sharp's level of regulatory and quality compliance.Furthermore, providing support for technical solutions that can assist with ongoing continuous improvement efforts and solutions identified as part of an ongoing CAPA effort.

Collaborate with senior management, Business Development, and Operations at specific sites to develop and execute the company's long-term growth strategy while earning double-digit sales growth annually.

Responsible for staying current and adhering to all Department policies, training and procedures related to the assigned new business development / project engineering resources.

Responsible for development and maintenance of an ongoing continuous improvement effort related to engineering and business practices including :

• Productivity tracking and improvement tools
• Technical Project management
• Individual project portfolio tracking and reporting

Interfaces with customers and vendors as required in supporting the Business Development Engineering function. Serves as the subject matter expert on customer owned packaging equipment, while fostering customer's confidence.

Responsible for development and drafting of specific project deliverables such as User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), and associated validation protocols as required. Assist in writing and reviewing specific procedures, cGMP's and SOP's as required including updating machine manuals, training checklists, etc..

Bring all aspects of the project together including the formulation of design for product handling, the filling process and the machinery to accomplish the above. Coordinates with Project Team Manager to assure technical project goals are aligned with overall project plan.

Responsible for the requisition of equipment whether purchased or designed to complete the project objective, on time and within budget.

Maintain and update engineering databases to maintain traceability and equipment history in records such as Blue Mountain Regulatory Asset Management (BMRAM), Sample Order, Tool Set Number and Tooling Number databases.

Demonstrate creativity and ingenuity in the solution of design problems on new and existing machinery.

Consider in the design project such factors as safety and ergonomics.

Review product design for compliance with engineering principles, company standards, and customer contract requirements, and related specifications.

Consults with management and reviews project proposals to determine goals, time frame, funding limitations, and procedures for accomplishing project, staffing requirements and allotment of resources.

Direct and coordinate activities of support personnel, whether internal or external, to ensure project progress is on schedule and within budget.

Develop detailed project timelines and status reports to keep management, customers, and others informed of project status and related issues.

Capable of self-motivation, working with minimal supervision. Must be a self-starter, persuasive and flexible in actions and assume project leadership in a fast-paced production environment.

QUALIFICATIONS :

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed herein are representative of the knowledge, skill, and / or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and / or EXPERIENCE

BS degree in an Engineering discipline with a minimum of 3 years related experience and / or training; or equivalent combination of education and experience. In addition, essential are direct experience in troubleshooting manufacturing lines; ability to plan and coordinate projects; strong written, verbal communication and presentation skills. Preferred attributes include working knowledge of applied manufacturing engineering principles; industry experience in food or pharmaceutical and experience working in FDA / cGMP compliance environments. Working knowledge of AutoCad is necessary and experience with Solidworks is a plus.

LANGUAGE SKILLS :

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and / or boards of directors.

MATHEMATICAL SKILLS :

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY :

Ability to demonstrate critical thinking skills including observation, analysis, interpretation, reflection, evaluation, inference, explanation, problem solving, and decision making. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

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. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel. The employee frequently is required to stand, sit, and talk or hear. The employee is occasionally required to walk; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and / or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT :

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.