Project Engineer

CIS Materials; Glenview (IL); Hybrid; USD 85,000 - 100,000; Full time

Job summary

Asahi Kasei Bioprocess America, Inc. in Glenview, IL is seeking a Project Engineer to lead the specification, design, manufacturing, qualification, and installation of capital equipment for pharmaceutical manufacturing, including chromatography, buffer formulation, virus filtration, and oligonucleotide synthesis systems.

You will manage customer requirements from concept through validation, work with suppliers and internal teams to select components, oversee equipment assembly, and lead

Qualifications

• Bachelor’s Degree in Engineering (Mechanical, Chemical, Electrical, Biomedical) required.
• 3–8 years’ experience building or operating process equipment in pharma.
• Familiarity with Quality Management Systems (ISO 9001:2015) and current GMP.

Responsibilities

• Own the project from concept through validation for capital equipment.
• Coordinate design, fabrication, installation, and commissioning activities.
• Develop and execute test protocols and acceptance testing with customers.
• Collaborate with suppliers and internal teams to meet schedule and budget.

Skills

Process equipment

On-site work

Team collaboration

Education

Bachelor's Degree in Engineering

Tools

ISO 9001 familiarity

Job description

## Project EngineerApply: Hybrid: Glenview, IL: Full time: Posted Today: R5899## The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.We are currently seeking applications to fill the following job opening at Asahi Kasei Bioprocess where we sell Planova virus removal filters and develops and manufactures related bioprocess equipment.**Company:**Asahi Kasei Bioprocess America, Inc.**Job Description:**Asahi Kasei Bioprocess America, Inc. (AKBA) provides pharmaceutical and biopharmaceutical manufacturers with a comprehensive suite of tools to maximize safety and improve yields of biotherapeutics during research, clinical and commercial-scale production. PlanovaTM virus-removal filters anchor a diverse product portfolio defined by quality, consistency and scalability. Additional areas of expertise include liquid chromatography, inline buffer dilution and oligonucleotide synthesis.We are a growing team (145+) of professionals excited about what we do and our ability to impact healthcare delivery systems worldwide. We offer a \"big company\" benefits package and a \"small company\" culture and work environment. Every employee at Asahi Kasei Bioprocess America can impact our future.As an Asahi Kasei Bioprocess America employee, you will enjoy:* Strong company culture* Competitive Compensation with Bonuses* Great health benefits with the company paying over 80% of insurance premiums* Wellness Program* Paid Time Off* Strong company match to 401(k) contributions* Tuition reimbursement program* Giving Program* Paid Parental Leave**Position Summary:**We are currently looking for a **Project Engineer** to join our team at AKBA! The individual in this role will lead the specification, design, manufacturing, qualification, and implementation of custom and standard capital equipment for pharmaceutical and biopharmaceutical manufacturing processes, including chromatography, buffer formulation, virus filtration, and oligonucleotide synthesis systems. Manage customer project requirements from concept through validation, ensuring technical, schedule, and budget objectives are achieved. Collaborate closely with customers, suppliers, and internal stakeholders to select components, oversee equipment assembly, support commissioning and validation activities, and lead installation, testing, and training at customer sites. Serve as a technical expert while maintaining a strong customer-focused approach and driving continuous improvement initiatives to enhance product quality, performance, and project execution.**Duties/Responsibilities:**Project Engineering:* Serve as the primary stakeholder and owner of customer equipment projects* Provide technical and practical expertise to support assigned Project Manager* Review detailed customer specifications and engage appropriate stakeholders to gain full understanding, be able to interpret requirements to relevant stakeholders when necessary.* Create and / or review design documents, including technical drawings and specification documents with input from subject matter experts* Specify appropriate components and materials in accordance with project requirements, subject matter expertise for process and design points (calculations and sizing), and consideration of vendor selection, component suitability and availability, price, and lead time* Advise Quality Control on specifications for component receipt and acceptance specific to a project* Execute commissioning and according troubleshooting on automated systems to achieve validation readiness or to address customer issues in the field* Write and execute detailed project-specific test protocols in accordance with GAMP and established templates and practices with guidance from Validation* Execute testing activities including mechanical, electrical, and automation commissioning, GAMP qualification, customer Factory Acceptance Testing and customer Site Acceptance Testing with support from Engineering, Validation, and/or Field Service* Construct user manuals and other customer-facing documents to comply with project requirements and realize customer satisfaction* Perform engineering review of final documentation turnover packages* Ensure that project scope is completely accounted for and supervise adequate packaging of all deliverables in preparation for transport* Travel to customer site for supervision of installation, testing of installed equipment, and operator training with support from Engineering, Validation, and/or Field ServiceProject Management:* Identify, clarify, and manage project scope internally and with customer, facilitating change orders as necessary* Employ effective communication strategies with internal and external project stakeholders, including recurring and ad-hoc meetings as appropriate* Develop and manage project schedule and communicate schedule updates and critical paths with stakeholders with support from Project Management if necessary* Communicate project budget for labor and materials and manage actively throughout the project to maximize project margin* Communicate with suppliers to manage delivery of components and materials and secure expediting when necessary* Communicate expectations and required milestone deliverables with internal departments including design, purchasing, assembly, automation, logistics, quality, and field service* Ensure project processes are executed and documented in accordance with established procedures and quality checks* Employ a customer-focused approach to each project to ensure customer satisfaction, trust, and long-term relationship buildingCustomer Support:* Manage assigned subset of customer accounts as the primary technical owner of products installed at customer sites by serving as the first line of support for all technical concerns or issues including customer inquiries, complaints, and upgrade requests using customer-focused approach* Address customer issues in person, over the phone, or via web-based tools by effectively communicating solutions to customer and providing effective training to relevant personnel* Entertain customers locally or at the customer’s facility when appropriate for a project by building relationships and spending social time after normal business hoursInternal Projects:* Contribute to or lead the realization of a new product offering from handover to Engineering from Design and Development through first customer order with support from Design & Development* Contribute to new product designs with innovative ideas, practical design feedback, and product risk/benefit analyses* Research technology, components, companies, or solutions that strengthen current and future product offerings* Propose and participate in or lead improvements to Engineering internal and interdepartmental processesAdditional Duties and Responsibilities:* Act as an ambassador of the organization* Adopt a 5-S and safety-first mentality throughout workspaces and responsibilities* Seek and participate in current, relevant technical training as well as non-technical training opportunities* Provide detailed subject matter training to colleagues and customers* Contribute technical expertise to Sales & Marketing for quotation support when requested for change orders to active projects* Contribute technical support to Quality for addressing customer feedback and supplier issues* Additional tasks as assigned by superior reporting chain**Qualifications/Requirements:*** Ability to work onsite at our Glenview, IL facility* Bachelor’s Degree in Engineering (Mechanical, Chemical, Electrical, Biomedical)* 3-8 years’ experience building or operating process equipment (preferably in pharmaceutical industry)* Licensed Professional Engineer not required, but considered a plus* Familiarity with Quality Management Systems (ISO 9001:2015 preferred) and current Good Manufacturing Practices* Awareness of personal strengths, weaknesses, and impact of decisions on wider team, department, and company* Eagerness to learn new technical information, new processes, and new skills* Willingness to assist outside of everyday responsibilities when required* Demonstration of these qualities: energetic, positive, strong interpersonal communicator, detail-oriented, ethics-minded, problem-solver, adaptable, team-oriented, customer-focused, and self-motivated**Physical Demands/Environmental Conditions:*** Travel several times (estimated 3-8 work weeks typical) in a year to visit domestic and international customer sites for project kickoffs, equipment installations, or other activities such as tradeshows (depending on individual assignments and quantity and scope of active projects)* Occasional exposure to pressurized liquids, live electrical circuits, and/or chemical solutions requiring proper personal protective equipment (provided)The base compensation range for this role is $85,000-$100,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.Please note, we will not be providing immigration-related sponsorship now or in the future for this role.#LI-BJ1