Engineering - Assistant Process Engineer#26-27862

Devens, MA

Onsite Job 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)

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."