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Assistant Process Engineer
Sunrise Systems Inc
- 🇺🇸 United States
- On-site
- 1 day ago
- Technical Writing
- GMP
1 day ago
Not enough detail in this posting to match
Location: Devens, MA 01434
Duration: 6 Months
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.
- 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.
- 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.
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com
Assistant Process Engineer · Sunrise Systems Inc