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.
Must Haves:
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
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.
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.
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
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Numbers & Facts
Location
Devens, MA
Skills
Analysis Skillsunmatched
Biochemistryunmatched
Budgetingunmatched
Chemical Engineeringunmatched
Chemistryunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Data Collectionunmatched
Data Processingunmatched
Detail Orientedunmatched
Documentationunmatched
GMP (Good Manufacturing Practices)unmatched
Identify Issuesunmatched
Manufacturingunmatched
Manufacturing/Industrial Processesunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Process Engineeringunmatched
QA Partner Testing Softwareunmatched
Quality Controlunmatched
Team Lead/Managerunmatched
Team Playerunmatched
Technical Writingunmatched
Writing Skillsunmatched
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