Process Engineer II

Join to apply for the Process Engineer II role at Bio Space.

Under the direction of the Manager for Process Engineering, contribute to the design, development and enhancement of manufacturing processes.

The primary responsibilities of this role are the execution of equipment and process improvement projects, to contribute to the design, development or enhancement of new and existing products and processes and being a system owner for manufacturing equipment and processes. Enhancing process knowledge and technical problem solving are major elements of this position. This position will provide technical support to the manufacturing and maintenance functions for the operation of equipment and processes.

• Perform standard engineering assignments which are typically a significant portion of a larger project. Select sound techniques to solve problems and make design recommendations under direction of the Manager. Assess results for application, validity and conformance to specifications. Recommend material and process specifications.
• Participate in technical problem solving for operational issues using engineering and scientific principles.
• Perform equipment testing and commissioning, and support qualification activities as needed.
• Lead/participate in process equipment improvement projects. This consists of identification and implementation of equipment and process changes in adherence with industry standards and company quality systems.
• Support manufacturing operations through the system owner concept. Remain responsible for equipment operating efficiencies and identification and resolution of systemic issues.
• Create detailed and accurate project schedules and budgets in accordance with the approved scope. Interface and align with cross‑functional groups. Remain accountable for projects timelines and spending. Identify and resolve issues that may jeopardize project schedules/scope/cost in a timely manner.
• Establish, develop and drive Good Engineering Practices and execute projects in accordance with the prescribed project management methodology.
• Manage contractors on projects.

• BS in Engineering and a minimum of 2 years related experience or MS in Engineering and 0‑2 years related experience required.
• Demonstrated success in delivering results in several technical challenges, Experience in the biopharmaceutical manufacturing environment related to Engineering, Project Management and Validation. The candidate must have good communication skills and the ability to perform effectively in multi‑disciplinary teams.
• Strong process engineering skills based on sound engineering and scientific principles.
• Extensive technical expertise and strong working knowledge of other related disciplines of engineering common to the business.
• Must have excellent communication skills in order to effectively communicate with all levels of professionals, both internal and external.
• Demonstrated ability in technical writing, describing complex processes and qualifications.
• Able to convince management on courses of action with minimal assistance using both written and verbal methods.
• Must be self‑motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
• Effective team member with experience in handling multiple projects and leading cross‑functional teams with minimal guidance.
• Able to prioritize multiple tasks.
• Able to incorporate cGMP concepts, quality systems requirements and safety into process and equipment design.
• Must be able to provide solutions that reflect an understanding of business objectives and cost implications.

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make‑up, jewelry,…