Assistant Process Engineer

Dexian; Acton (MA); Presencial; USD 110 000 - 150 000; Tempo integral

Resumo da oferta

Dexian is seeking an MSAT Process Engineering Contractor to support GMP manufacturing investigations, focusing on OOS and deviation investigations. The role involves reviewing batch records, process data, equipment logs, and analytical results, while collaborating with QA, QC, Manufacturing, and Engineering teams.

The ideal candidate has 2+ years of industry experience, a relevant Bachelor's degree, and strong technical writing and problem-solving skills.

Qualificações

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or a related technical field.
• Minimum 2 years of industry experience.
• Experience in a cGMP environment or cell therapy manufacturing.
• Strong technical writing and documentation skills.
• Experience with OOS investigations, troubleshooting, and problem-solving.

Responsabilidades

• Support and, when appropriate, take ownership of OOS investigations.
• Review batch records, process data, equipment logs, and analytical results.
• Partner with Quality Assurance, Quality Control, Manufacturing, and Engineering teams.
• Gather and analyze data to determine investigation scope and conclusions.
• Prepare technical documentation, including investigation reports and impact assessments.
• Present investigation findings and technical rationale to cross-functional teams and management.

Conhecimentos

Technical writing

Problem-solving

Analytical thinking

Cross-functional collaboration

Communication

Quality systems

Formação académica

Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or related field

Ferramentas

Electronic data systems

Descrição da oferta de emprego

The MSAT Process Engineering Contractor will support GMP manufacturing investigations, mainly OOS and deviation investigations. The role involves reviewing batch records, process data, equipment logs, and analytical results, while working with QA, QC, Manufacturing, and Engineering teams. Candidates need 2+ years of industry experience, a relevant Bachelor's degree, strong technical writing/problem-solving skills.

Key Responsibilities:

• Support and, when appropriate, take ownership of OOS investigations.
• Review batch records, process data, equipment logs, and analytical results.
• Partner with Quality Assurance, Quality Control, Manufacturing, and Engineering teams.
• Gather and analyze data to determine investigation scope and conclusions.
• Prepare technical documentation, including investigation reports and impact assessments.
• Present investigation findings and technical rationale to cross-functional teams and management.

Required Qualifications:

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or a related technical field.
• Minimum 2 years of industry experience.
• Experience working in a cGMP environment or cell therapy manufacturing.
• Strong technical writing and documentation skills.
• Experience with OOS investigations, troubleshooting, and problem-solving.
• Familiarity with GMP documentation and electronic data systems.
• Strong analytical, critical-thinking, communication, and presentation skills.
• Ability to work effectively with cross-functional teams in a fast-paced environment.

Preferred:

• Experience with cell therapy manufacturing processes.
• MSAT or biopharmaceutical manufacturing experience.
• Experience with deviation investigations, root cause analysis, and impact assessments.

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support. Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.