Senior Project Engineer

Sharp Services•Allentown, PA

About The Position

Sharp is seeking a Senior Project Engineer to lead engineering functions for new business development projects and strategic capital programs. This role involves managing all engineering aspects of new business projects, from design and specifications to procurement and implementation of equipment, tooling, and technology. The Senior Project Engineer will act as a technical liaison for customers, serve as a subject matter expert for both Sharp and customer-owned equipment, and collaborate with Account Executives to support new business development. The position requires driving the design and development of assembly and packaging projects, supporting validation of packaging processes, and providing technical support to production operations to improve efficiency, quality, and equipment performance. The role also involves conducting technical evaluations of equipment and industry technologies, identifying and implementing process improvements for regulatory compliance and continuous improvement, and collaborating with senior management on long-term growth strategies. Maintaining compliance with departmental policies and leading continuous improvement initiatives are key responsibilities. The Senior Project Engineer will interface with customers and vendors, develop project documentation (URS, FRS, FAT, SAT, etc.), manage equipment procurement, maintain engineering records, solve design challenges, and review designs for compliance. Evaluating project proposals, directing resources, and communicating project status are also integral parts of the role. Strong analytical, problem-solving, organizational, and communication skills are essential, along with the ability to work independently and lead in a fast-paced manufacturing environment.

Requirements

Bachelor’s degree in engineering (Mechanical, Industrial, Chemical, or related field) required.
Requires 7 plus years of experience in project engineering, capital projects, or manufacturing environments.
Demonstrated expertise in project management methodologies, budgeting, and cross-functional leadership is required.
Candidates must have direct experience troubleshooting manufacturing lines, as well as the ability to effectively plan, coordinate, and execute projects.
Proficiency in project management tools and Microsoft Office is required.
Working knowledge of AutoCAD is necessary.

Nice To Haves

Experience in SolidWorks considered a plus.
Familiarity with corporate engineering standards, safety regulations, and continuous improvement practices is expected.
Applied pharmaceutical manufacturing engineering experience.
Working knowledge of FDA/cGMP compliance standards.

Responsibilities

Drive the design and development of assembly and packaging projects for new product launches and processes, including technical project management, identification of customer needs, translation of requirements into design specifications, process development, equipment selection, qualification, and implementation in production environments.
Support validation of packaging processes using technical expertise in equipment parameters, capabilities, and product functional requirements.
Provide technical support to production operations by identifying and implementing solutions to improve process efficiencies, product quality, and equipment performance, including repair and upgrades as needed.
Collaborate with Account Executives to effectively communicate technical capabilities, innovations, and solutions to customers in support of new business development.
Conduct ongoing technical evaluations of packaging equipment and industry technologies, including gap analysis, and develop solutions and improvement plans to enhance company capabilities and competitiveness.
Identify and implement technical and process improvements to enhance regulatory compliance, quality standards, and continuous improvement initiatives, including CAPA efforts.
Collaborate with senior management, Business Development, and Operations to support execution of long-term growth strategies.
Maintain compliance with departmental policies, training requirements, and procedures related to project engineering and business development activities.
Lead and support continuous improvement initiatives related to engineering and business practices, including productivity tracking, project management, and project portfolio reporting.
Interface with customers and vendors as needed; serve as a subject matter expert on customer-owned packaging equipment while building and maintaining customer confidence.
Develop and manage project documentation, including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), validation protocols, SOPs, and cGMP documentation.
Coordinate all technical aspects of projects, including product handling, filling processes, and machinery design, ensuring alignment with overall project plans.
Manage equipment procurement (designed or purchased) to meet project scope, timeline, and budget requirements.
Maintain accurate engineering records and databases (e.g., BMRAM, tooling and sample order systems) to ensure traceability and equipment history.
Apply creativity and engineering expertise to solve design challenges for new and existing machinery, with consideration for safety, ergonomics, and operational efficiency.
Review product and process designs for compliance with engineering principles, company standards, customer requirements, and applicable regulations.
Evaluate project proposals with management to define scope, timelines, budgets, resource allocation, and staffing requirements.
Direct and coordinate internal and external resources to ensure projects are completed on schedule and within budget.
Develop and communicate detailed project timelines, status updates, and performance reports to stakeholders.
Demonstrate strong analytical, problem-solving, organizational, and communication skills (written, verbal, and presentation).
Operate with a high degree of independence, initiative, and flexibility, providing project leadership in a fast-paced manufacturing environment.