Process Engineer II, Manufacturing Engineering
Process Engineer II, Manufacturing Engineering
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 hazardous/toxic materialsJob 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
Bachelors 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.
Employment Type
Full-Time
