Job Description:
At Asahi Kasei we believe anyone can buy equipment or build a facility. It is our diverse team members around the globe who will enable us to develop ideas and technologies and capture the exciting opportunities that lie ahead. We look for candidates with a fresh perspective, people with a wide variety of skills who are creative thinkers, enjoy challenges and are driven to excel.
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:
About Asahi Kasei Bioprocess America, Inc .
Asahi Kasei Bioprocess (AKB) 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 (100+) 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.
We are currently looking for a Senior Project Engineer to join our team. This individual will manage the specification, design, manufacture, and qualification of custom and standard capital equipment used for pharmaceutical and biopharmaceutical product manufacturing (example equipment types include chromatography, buffer formulation, virus filtration, oligonucleotide synthesis).:
fully manage and direct project requirements and specifications for all of project team
interfacing effectively with customer stakeholders
making sound component and sub-supplier selections
managing project timelines and budgets
commissioning and validating assembled equipment
participating in customer site installation, testing, and training
applying customer-focused mindset
pursuing continual improvement
Key Responsibilities:
Project Engineering
Serve as the primary stakeholder and owner of customer equipment projects
Provide technical and practical expertise to support Project Manager
Review and understand detailed customer specifications and interpret requirements to appropriate stakeholders
Create and / or review design documents, including technical drawings and specification documents
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 approval specific to the project
Write and execute detailed project-specific test protocols in accordance with GAMP and established templates and practices. Testing activities include mechanical and automation commissioning, GAMP qualification, customer Factory Acceptance Testing and customer Site Acceptance Testing
Construct user manuals and other customer-facing documents to comply with project requirements and realize customer satisfaction, and perform engineering review of final documentation turnover packages
Travel to customer site for supervision of installation, testing of installed equipment, and operator training
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 schedule updates and critical paths with stakeholders
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
Customer 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
Internal Projects
Lead the realization of a new product offering from handover to Engineering from Design and Development through first customer order
Contribute to new product designs with innovative ideas, practical design feedback, and product risk/benefit analyses
Requirements:
Bachelor's Degree in Engineering (Mechanical, Chemical, Electrical, Biomedical)
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
Possess these qualities: energetic, positive, strong interpersonal communicator, detail-oriented, ethics-minded, problem-solver, adaptable, team-oriented, customer-focused, and self-motivated
Travel 3 to 10 weeks in a year to visit domestic and international customer sites for project kickoffs, equipment installations, or other activities (depending on individual assignments and quantity and scope of active projects)
As an Asahi Kasei Bioprocess America employee, you will enjoy:
Competitive compensation with bonuses
Great health and wellness benefits
Paid time-off
Strong company match to 401(k) contributions
Tuition reimbursement program
Company Giving and Volunteering Program
We believe a diverse workforce is crucial to our growth as a global supplier of advanced materials. Asahi Kasei is an equal opportunity employer.
