Assistant Process Engineer

Mindlance; Harvard (MA); Hybrid; USD 55,000 - 83,000; Full time

Job summary

Mindlance seeks a MSAT Process Engineering Contractor/Assistant Process Engineer to support Manufacturing Science and Technology (MSAT) activities at our Devens, MA site, with a focus on Out-of-Specification (OOS) investigations and cross-functional collaboration.

The candidate should have a Bachelor's in Chemical/Biochemical Engineering or Chemistry and up to 2 years of industry experience, plus strong technical writing, analytical, and presentation skills.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or related technical discipline.
• 0–2 years of industry experience; cGMP or Cell Therapy manufacturing experience.
• Strong technical writing for 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, cross-functional with Quality, Manufacturing, and Engineering.

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.

Skills

cGMP knowledge

Cell therapy manufacturing

Technical writing

Analytical thinking

Cross-functional communication

Problem solving

Education

Bachelor's degree in Chemical/ Biochemical Engineering or Chemistry

Job description

Location: Devens, MA – 01434 | Hybrid - Candidates must be 50% onsite

Project Duration: 06 Months (Possibilities of extension)

(W2 Assignment)

Work Schedule: Mon-Fri(normal business hours)

Duration: 6 months(Possibility of extension for the right candidate depending on performance and budget)

Top Requirements:

• 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 Description:

• The MSAT Process Engineering Contractor/ Assistant Process Engineer 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.

Equal Employment Opportunity: “Mindlance is an Equal Opportunity Employer and does not discriminate in employment based on race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.”