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 (140+) 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 built on trust, collaboration, and community
Competitive Compensation with Bonuses
Great health benefits with the company paying over 80% of insurance premiums
Paid Time Off
Strong company match to 401(k) contributions
Tuition reimbursement program
Paid Parental Leave
We are currently looking for a Senior Product Development Engineer to join our team at AKBA! The qualified individual will be responsible for managing and advising the specification and design of new pharmaceutical and biopharmaceutical process equipment, product improvements, features, and services from concept through product launch. The qualified individual will have the opportunity to provide experienced insight and advice for application challenges and design problems as well as lead and manage development of documentation and design inputs and outputs to ensure timely and complete gate pass-through for gated product development process.
Research technology, components, companies, or solutions that strengthen our current and future product offerings.
Confirm boundaries of existing patents and understand gaps and opportunities for new ones.
Propose new product designs with innovative ideas, practical design feedback, and product risk/benefit analyses.
Serve as the primary technical stakeholder and owner of assigned new product and/or feature development projects.
Provide technical and practical expertise to support assigned Project Manager.
Review, understand and translate for project stakeholders required specifications, project challenges, and desired outcomes.
Create and / or review design documents, including technical drawings and specification documents.
Specify and partner with suppliers to obtain 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 approval specific to the project.
Consult for creation of detailed project-specific test protocols in accordance with GAMP and established templates and practices by Validation stakeholders.
Construct FRS, user manuals and other customer-facing documents and resources to comply with project requirements and realize customer satisfaction.
Collaborate with Sales and Marketing to understand the voice of the customer, the trends of the market, and the strengths and weaknesses of competitor offerings.
Ensure that project scope is completely accounted for prior to handoff to Sales and/or Engineering and provide continuing support for first several prototypes and customer units.
Liaising to the Project Engineering team and Product Managers to ensure complete tech transfer from Development to Production.
Establishes explicitly clear product standards and definition as part of the development project turnover to Sales and Engineering (Product Management foundation).
Leverage subject matter expertise to execute unscripted testing, identify edge conditions, discover system shortcomings, and document opportunities for improvement.
Review customer specification for bids and new projects and communicate elements of note or concern.
Contribute to design reviews and provide technical and practical expertise to active customer projects as required.
As a subject matter expert, assist internal project teams with troubleshooting, supplier management, and technical recommendations for product and project optimization.
Support Engineering as expert consultant for internal or customer issues regarding process or equipment.
Support customer service and project teams for technical 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.
Delegate execution of issue resolution to appropriate department.
Additional Duties and Responsibilities:
Seek and participate in current, relevant technical training as well as non-technical training opportunities.
Provide subject matter training to colleagues and customers.
Contribute technical expertise to Sales & Marketing for URS development, product launch materials, transition of product to sales.
Contribute technical support to Quality for addressing customer feedback and supplier issues surrounding newly launched products.
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 internal and external customer satisfaction, trust, and long-term relationship building.
Bachelor's Degree in Engineering (Mechanical, Chemical, Electrical, Biomedical).
10+ years' experience building or operating process equipment (preferably in pharmaceutical industry).
Demonstrated innovation (IP portfolio) considered a strong plus.
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.
Possess these qualities: energetic, positive, strong interpersonal communicator, detail-oriented, ethics-minded, problem-solver, adaptable, team-oriented, customer-focused, and self-motivated.
Physical Demands/Travel Requirements:
Travel 4 to 5 weeks in a year to visit domestic and international customer sites for customer visits, vendor audits, and industry trade events.
Occasional exposure to pressurized liquids, live electrical circuits, and/or chemical solutions requiring proper personal protective equipment (provided).