Process Engineer II, Manufacturing Engineering

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardotoxic materials

Job Description

Process Engineer II will support the clinical and commercial drug manufacturing in Plainville, MA. Scope includes designing, specifying, and supporting manufacturing equipment such as fill lines, bioreactors, chromatography and TFF systems, autoclaves, and analytical equipment in our recently built viral vector facility. The individual will join a dedicated team of process engineers working closely with groups such as manufacturing, automation, quality assurance, quality control and validation.

Responsibilities:

• Implement manufacturing equipment involved in tech transfers of new products into manufacturing and provide continued engineering support throughout manufacturing campaigns.
• Support all aspects of the process equipment for upstream, downstream, and fill/finish operations, including support of FAT, SAT, and commissioning/qualification activities.
• Participate and lead site teams for process equipment introduction and modification.
• Develop equipment specifications for manufacturing equipment and prepare lifecycle documentation such as user requirements, instrument assessments, and preventative maintenance plans.
• Build and maintain relationships within the Plainville site to develop and promote engineering standard methodologies and ensure compliance with SOPs, safe work practices, and cGMP regulations. The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams.
• Position requires ability to support on-call requirements for client programs. Colleagues will be readily available to respond to production needs outside of core business hours ensuring business continuity. The on-call responsibilities typically rotate weekly through the engineering team.

Education

Bachelor's degree in engineering, science or related field.

Experience

• Minimum of 2 years experience in process development, operations, or engineering in a GMP-related industry.

Knowledge, Skills, Abilities

• Working understanding of general cGMP standards and practices
• Understanding of process equipment and unit operations (Bioreactors, Chromatography, TFF, Autoclaves, media/buffer preparation, etc.) and associated process utility systems
• Comfortable supporting concurrent issues and working in an exciting and fast-paced environment.
• High ethical standards to support a professional business code of conduct.