Senior Process Engineer (cGMP – Pharmaceutical)            JD817642

Boston, MA area

DPS is looking for a talented and experienced Process Engineer to work with a pharmaceutical client in the Boston, MA area. Ideal candidates should have a strong understanding of the engineering lifecycle related to biotech and pharmaceutical GMP industries. This individual must be strong technically with Cell Culture equipment (Bioreactors, Media and Harvest Vessels, Process, SIP and CIP transfer lines). They would be expected to review protocols, specifications and reports as part of a larger Cell Culture project. Experience with process facility design and construction in clean room, laboratories, biotech, pharma, nanotechnology and life science to work with clients, vendors and Design Engineers and execute projects for Biotech and Pharmaceutical clients.

Responsibilities:

• Must have must strong technical knowledge related to Cell Culture equipment i.e. Bioreactors, Media and Harvest Vessels, Process, SIP and CIP transfer lines.
• Provide process design input on behalf of the client throughout the design engineering lifecycle so that design deliverables are achieved in a timely manner.
• Work directly with lead engineers to oversee and manage various capital and operational improvement projects for the Client.
• Provide knowledge and expertise for process equipment, utilities and facility design related projects not limited to Upstream, Downstream processes, CIP, SIP, and other process systems.
• Demonstrated understanding of fermenters, bioreactors, centrifuges, UF/DF skids, viral filtration, chromatography, and other Biotech/Pharma process equipment is preferred.
• Must have strong understanding of Quality Systems within a GMP manufacturing environment.

• Use experience with process facility design and construction in clean room, laboratories, biotech, pharma, nanotechnology and life science to work with clients, vendors and design engineers and execute projects for biotech and pharmaceutical clients.

Qualifications:

• Bachelor’s degree in Chemical or Mechanical Engineering or equivalent, plus 2 years of experience in a GMP or highly regulated engineering environment including upstream and downstream biopharmaceutical facility design, troubleshooting, start-up and commissioning at a senior level working with clients, vendors and other design engineers to execute projects for biotech and pharmaceutical clients. 
• 7+ years of process engineering experience involving: cell culture, upstream and downstream purification, single-use technology, and multiple-use technology is preferred.
• Previous experience working in the Biotech/Pharma industry is required.
• Strong project management and leadership skills preferred (ability to collaborate and lead a team against tight project timelines).
• Strongly motivated, well-organiz531758.752446ed, and shows professional initiative.
• Takes ownership of assignments, can work both independently and as part of the team.
• Ability to work in a fast-paced and challenging environment.
• Excellent organiz531758.752446ation skills with the ability to manage multiple tasks simultaneously.
• Must be able to manage and lead people effectively.