Aseptic Process Engineer Jobs in Raleigh, NC (NOW HIRING)

Precis Engineering + Architecture (Precis) is a 150+ person consulting firm with offices in Ambler, Pa., and Cary, N.C., offering comprehensive design services. Precis has been repeatedly recognized as a Best Place to Work by the Philadelphia Business Journal.

The Senior Process Engineer supports the Cary, N.C., office with 10 years or more of experience focusing on the design and implementation of clean utility systems (WFI generation and purified water systems) and equipment cleaning in place (CIP) systems for the pharmaceutical, biotechnology, and/or chemical industries. This individual must have a strong engineering background and a thorough understanding of equipment design, CIP design, US Pharmacopeia and BPE standards. A candidate with a strong engineering background and understanding of aseptic fill/finish process methodologies and equipment is also highly desirable.

The individual will be resourceful and goal-oriented, desiring challenging work in a dynamic environment. Process is a younger business endeavor for Precis, and this individual will have an entrepreneurial and strategic mindset toward long-term growth and viability of the group. The ideal candidate will be comfortable in a process lead and project manager role as well as representing the automation discipline as a technical resource on larger, multi-discipline project teams. The individual will be responsible for generating process-related project deliverables such as P&IDs, utility diversity calculations, user requirements, equipment specifications, piping approach and design, and corresponding narratives/reports.

• Responsible for management and coordination of multi-discipline engineering teams for process projects comprised of Precis, client, and third-party personnel.
• Subject matter expert in design and implementation for process and clean utilities for pharmaceutical manufacturing clients.
• Proficient in the design and implementation of aseptic fill/finish process methodologies and equipment.
• Experience with major clean utility and cleaning equipment manufacturers.
• Familiarity with instrumentation and automation and control approaches.
• Knowledge of cGMP requirements with respect to operations and manufacturing facility design.
• Ability to communicate and articulate process design deliverables and convey the project needs to complete process deliverables to clients and partners.
• Assist in managing and performing quality reviews on Precis and sub-contracted third-party deliverables and submittals.
• Develop new clients; maintain and expand the relationship and scope of work with existing clients.
• Determine project requirements, customer requirements, performance standards, and complete technical studies; prepare cost estimates.
• Prepare proposals in response to RFPs.
• Process engineering with a focus on process utilities and CIP equipment
• Process engineering with a focus on a defined pharmaceutical process
• Specification of process equipment and instrumentation
• Business development and client management
• Strategic thinking. problem solving, and analysis
• Customer/client focus
• Time management
• Team leadership

• B.S. or M.S. in Chemical or Industrial Engineering or related major required.
• Professional Engineer license preferred.
• Minimum of 10 years of experience in the field.
• The ability to work well with others, lead a team, and manage in matrix teams and environments with multiple clients.
• Experience in process utility design and implementation.
• Experience in pharmaceutical process design and implementation.
• Experience in process deliverables such as process flow diagrams, P&IDs, and equipment specifications.
• Delegation, mentoring, negotiating, and team skills.
• Effective presentation, written and verbal communication skills.
• Excellent organizational, planning, and time management skills.
• Logical thinking with creative problem-solving skills.
• Understanding of budget control.
• Familiarity with a variety of the field’s concepts, practices, and procedures.

• Be part of a collaborative, innovative team that values your ideas and expertise.
• Shape growth for a respected, specialized engineering and architecture firm.
• Enjoy a flexible, supportive work environment and competitive compensation package.

Precis provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics.