Project Engineer

Asahi Kasei•Glenview, IL

1d•Onsite

About The Position

Asahi Kasei Bioprocess America, Inc. (AKBA) is seeking a Project Engineer to lead the specification, design, manufacturing, qualification, and implementation of custom and standard capital equipment used in pharmaceutical and biopharmaceutical manufacturing. Equipment and processes include chromatography, buffer formulation, virus filtration, and oligonucleotide synthesis systems. The Project Engineer manages customer requirements from concept through validation, ensuring technical, schedule, and budget objectives are achieved. The role works closely with customers, suppliers, and internal stakeholders to select components, oversee assembly, support commissioning and validation, and lead installation, testing, and training at customer sites. It also serves as a technical resource for assigned customer accounts and contributes to new product development and improvements to engineering and cross-functional processes. The position is based onsite at the Glenview, Illinois facility and includes several weeks of domestic and international travel in a typical year, depending on assignments and project scope.

Requirements

Ability to work onsite at the Glenview, Illinois facility.
Bachelor's degree in Engineering, such as Mechanical, Chemical, Electrical, or Biomedical Engineering.
3–8 years of experience building or operating process equipment; experience in the pharmaceutical industry is preferred.
Demonstrated ability to communicate effectively and work with customers and internal stakeholders.
Detail-oriented, ethical, adaptable, team-oriented, customer-focused, energetic, positive, self-motivated, and skilled at problem-solving.
Awareness of personal strengths and weaknesses and how decisions affect the wider team, department, and company.
Eagerness to learn technical information, processes, and skills.
Willingness to assist outside everyday responsibilities when required.

Nice To Haves

Licensed Professional Engineer (not required).
Familiarity with Quality Management Systems, preferably ISO 9001:2015, and current Good Manufacturing Practices.

Responsibilities

Serve as the primary stakeholder and owner of customer equipment projects, providing technical and practical expertise to support the assigned Project Manager.
Review customer specifications, understand requirements, and communicate relevant requirements to stakeholders.
Create or review design documents, technical drawings, and specification documents with subject matter experts.
Specify components and materials based on project requirements, process and design considerations, vendor selection, suitability, availability, price, and lead time.
Advise Quality Control on project-specific component receipt and acceptance specifications.
Commission and troubleshoot automated systems to prepare them for validation or address customer issues in the field.
Write and execute project-specific test protocols in accordance with GAMP and established templates and practices.
Execute mechanical, electrical, and automation commissioning, GAMP qualification, customer Factory Acceptance Testing, and customer Site Acceptance Testing with support from relevant teams.
Prepare user manuals and other customer-facing documents and review final documentation turnover packages.
Ensure project scope and deliverables are accounted for and adequately packaged for transport.
Travel to customer sites to supervise installation, test installed equipment, and train operators.
Identify, clarify, and manage project scope with internal stakeholders and customers, facilitating change orders as needed.
Communicate with internal and external project stakeholders through recurring and ad-hoc meetings.
Develop and manage project schedules and communicate updates and critical paths.
Communicate and manage labor and materials budgets to maximize project margin.
Coordinate with suppliers to manage component and material deliveries and expedite when needed.
Communicate expectations and milestone deliverables to design, purchasing, assembly, automation, logistics, quality, and field service teams.
Ensure project processes are performed and documented in accordance with established procedures and quality checks.
Maintain a customer-focused approach to build satisfaction, trust, and long-term relationships.
Manage assigned customer accounts as the primary technical owner of installed products and first line of support for technical concerns, inquiries, complaints, and upgrade requests.
Address customer issues in person, by phone, or through web-based tools, communicating solutions and providing training.
Entertain customers locally or at customer facilities when appropriate, including spending social time after normal business hours.
Contribute to or lead the realization of new product offerings from engineering handover through the first customer order.
Contribute innovative ideas, practical design feedback, and product risk/benefit analyses to new product designs.
Research technologies, components, companies, and solutions that can strengthen current and future product offerings.
Propose, participate in, or lead improvements to Engineering and interdepartmental processes.
Act as an ambassador for the organization and maintain a 5-S and safety-first mentality.
Participate in relevant technical and non-technical training and provide subject matter training to colleagues and customers.
Provide technical expertise to Sales & Marketing for quotation support and to Quality for customer feedback and supplier issues.
Perform additional tasks as assigned by the reporting chain.