Process Engineer II

Role Summary

Process Engineer II: Under the direction of the Manager for Process Engineering, contribute to the design, development and enhancement of manufacturing processes. The primary responsibilities include execution of equipment and process improvement projects, contributing to design, development or enhancement of new and existing products and processes, and serving as a system owner for manufacturing equipment and processes. Provide technical support to manufacturing and maintenance functions for operation of equipment and processes.

Responsibilities

• Perform standard engineering assignments which are 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, identifying and implementing 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 project 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.

Qualifications

• BS in Engineering with a minimum of 2 years related experience or MS in Engineering with 0-2 years related experience.
• Demonstrated success in delivering results in several technical challenges, with experience in the biopharmaceutical manufacturing environment related to Engineering, Project Management and Validation. Strong communication skills and ability to work 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 engineering disciplines.
• Excellent communication skills to effectively communicate with all levels of professionals, internal and external.
• Proven technical writing ability, describing complex processes and qualifications.
• Ability to persuade management on courses of action with minimal assistance using written and verbal methods.
• Self-motivated with good interpersonal skills; capable of analyzing and solving complex problems through innovative thought and experience.
• Effective team member with experience handling multiple projects and leading cross-functional teams with minimal guidance.
• Ability to prioritize multiple tasks.
• Ability to incorporate cGMP concepts, quality systems requirements and safety into process and equipment design.
• Ability to provide solutions aligned with business objectives and cost implications.

Education

• BS in Engineering or MS in Engineering as specified in qualifications.