Senior Project Engineer

Sharp Corporation; Allentown (Lehigh County); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

Sharp Packaging Services is seeking a Senior Corporate Project Engineer to lead design and execution of assembly and packaging projects for new product launches. You will coordinate technical activities across design, process development, and production, acting as the liaison to customers and Account Executives.

You will guide validation, drive process improvements, and ensure compliance with FDA/cGMP standards while coordinating resources to meet schedule and budget in a fast-paced

Formación

• Bachelor’s degree in engineering; 7+ years in project engineering or manufacturing.
• Strong project management, budgeting, and cross-functional leadership.
• Proficiency in Microsoft Office; AutoCAD experience required; SolidWorks a plus.
• Familiarity with FDA/cGMP compliance.

Responsabilidades

• Lead design and development of assembly and packaging projects for new product launches.
• Support validation of packaging processes with equipment parameters and requirements.
• Provide technical support to production to improve processes, quality, and equipment performance.
• Collaborate with Account Executives to communicate capabilities to customers.
• Evaluate packaging equipment and technologies; develop improvement plans.
• Ensure regulatory compliance, quality standards, and CAPA initiatives.
• Coordinate with senior management to support long-term growth strategies.
• Develop and manage project documentation (URS, FRS, FAT, SAT).

Conocimientos

Project management

Cross-functional leadership

Budgeting

Analytical skills

Communication

Educación

Bachelor's degree in engineering

Herramientas

AutoCAD

SolidWorks

Descripción del empleo

Health and science don’t stand still, and neither do we. We’re curious. And we treat every day as a chance to learn and innovate — as individuals and as an organization.

You’ll be a great fit with Sharp if you:

• Embrace innovation
• Volunteer new ideas
• Enjoy expanding your own skills and knowledge

Senior Corporate Project Engineer

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

• 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.

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

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, with experience in SolidWorks considered a plus. Familiarity with corporate engineering standards, safety regulations, and continuous improvement practices is expected. Preferred qualifications include applied pharmaceutical manufacturing engineering experience, as well as working knowledge of FDA/cGMP compliance standards.

SUPERVISORY RESPONSIBILITIES

May directly supervise 1 to 3 Engineering personnel, providing both functional and technical leadership. Responsibilities include overseeing day‑to‑day activities in accordance with organizational policies and applicable laws, including interviewing, hiring, training, input on performance reviews, and employee development. Responsible for planning, assigning, and directing work; evaluating performance; recognizing achievements; addressing employee concerns; and resolving issues effectively.

ABOUT US

Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600‑strong team works from state‑of‑the‑art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost‑effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.