Project Engineer

AK America; Glenview (IL); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Bonuses

Health benefits

Paid time off

401(k) match

Tuition reimbursement

Parental Leave

Job summary

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

You will manage customer project requirements from concept through validation, collaborate with customers, suppliers and internal teams, and drive commissioning,

Responsibilities

• Lead the specification, design, manufacturing, qualification and implementation of custom and standard capital equipment for pharmaceutical and biopharmaceutical processes.
• Manage customer project requirements from concept through validation, ensuring technical, schedule and budget objectives are met.
• Collaborate with customers, suppliers and internal stakeholders to select components, oversee assembly, support commissioning and validation activities, and lead installation, testing and training at customer sites.

Job description

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. Planova™ 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 Service

Project 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