IR
Assistant Process Engineer
Integrated Resources, Inc
- 🇺🇸 United States
- Hybrid
- 1 day ago
- Technical Writing
- GMP
1 day ago
Not enough detail in this posting to match
Description: 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 Product 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.
Assistant Process Engineer · Integrated Resources, Inc