The Process Engineer will serve as a Technical Lead for Capital projects, overseeing GMP manufacturing process equipment at the manufacturing facility in Norwood, MA. This individual will collaborate closely with MS&T, Facilities, Validation, and equipment End Users to successfully drive projects to completion. The ideal applicant will thrive in a fast-paced, dynamic, and innovative environment, and will play a critical role with ensuring that their projects are executed efficiently and effectively to meet objectives and timelines.
Job Responsibilities
Provide direct engineering support and Subject Matter Expertise for process equipment in use at Norwood, MA (Ultrafiltration, Chromatography, Mixing Systems, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc.).
Drive results by owning and completing large sized projects with challenging timelines and complex subject matter. Skills required to meet expectations of the role include high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted.
Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor, in addition to reviewing and guiding the work of their immediate and cross-functional support teams.
The Process Engineer will participate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.
Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated Change Controls.
Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required. Provide input into preventative maintenance plans, assessing Change Controls, and continuous improvement initiatives.
Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment.
Education & Qualifications
A bachelor's degree in Chemical or Mechanical Engineering
Minimum of 8 years relevant experience as a Process Engineer
6 years of experience in a GxP environment preferred
Experience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc.)
Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required.
Must be able use his/her technical background to investigate issues using a structured problem-solving approach to determine root cause and develop effective corrective and preventative actions. Must be able to be able to find root cause and path forward for complex problems.
Familiarity with Microsoft Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred.
Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.
Ability to represent interests, objectives, and policies in a professional and responsible manner.