Partner with Quality Assurance, Quality Control, Manufacturing, and Engineering teams to gather data and align on investigation scope and conclusions. Qualifications: " Required Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or related technical discipline.
Numbers & Facts
Location
Devens, MA
Description
Engineering - Assistant Process Engineer
Minimum 50% onsite required
Work Schedule: Mon-Fri(normal business hours)
Duration: 6 months(Possibility of extension for the right candidate depending on performance and budget)
Job Description:
The MSAT Process Engineering Contractor will support Manufacturing Science and Technology (MSAT) activities. There will be a focus on Out-of-Specification (OOS) investigations.
Job Responsibilities:
" Support OOS investigations; may take on investigation ownership as appropriate.
" Review batch records, process data, equipment logs, and analytical results to support investigation findings.
" Partner with Quality Assurance, Quality Control, Manufacturing, and Engineering teams to gather data and align on investigation scope and conclusions.
" Present investigation findings and technical rationale to cross-functional teams and management as required.
Qualifications:
" Required Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or related technical discipline.
" Minimum 0 2 years of industry experience; cGMP or Cell Therapy manufacturing experience.
" Strong technical understanding of cell therapy manufacturing processes(Preferred)
" Technical writing skills for authoring impact assessments and out-of-specification investigations.
" Strong problem-solving, troubleshooting, and presentation skills.
" Familiarity with GMP documentation and electronic data systems.
" Ability to work collaboratively in a fast-paced environment.
" Strong analytical and critical-thinking skills with attention to detail.
" Effective communicator, able to work cross-functionally with Quality, Manufacturing, and Engineering stakeholders.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.