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Integrated Resources, Inc ( IRI )
Manufacturing Technical Services Engineer

Manufacturing Technical Services Engineer

On site

Cambridge, United states

$ 37 /hour

Junior

Freelance

06-11-2025

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Skills

Communication Data Analysis Statistical Analysis Process Improvement

Job Specifications

Job Summary:

The Engineer II (MTS) will be a key member of the Manufacturing Technical Services team, supporting late-stage and commercial drug product manufacturing. This role is responsible for technology transfer, process scale-up, optimization, and continuous improvement to ensure robust and compliant production of Alnylam’s RNAi therapeutics.

The successful candidate will collaborate with cross-functional teams to implement process improvements, analyze manufacturing data, and assist in validation activities to ensure GMP compliance and product quality.

Key Responsibilities:

Technology Transfer: Support process scale-up, optimization, and transfer to Contract Manufacturing Organizations (CMOs). Participate in due diligence and technical assessments for readiness.
Manufacturing Support: Assess deviations, contribute to change control documentation, and support CAPA development and risk assessments related to drug product manufacturing.
Data Analysis: Collect, analyze, and trend process data to generate reports and presentations for internal stakeholders.
Continuous Improvement: Identify and implement opportunities for process optimization and efficiency improvements.
Validation and Launch Support: Support development and execution of validation protocols, sampling plans, and documentation of validation activities.
Compliance: Demonstrate knowledge of cGMP principles and regulatory requirements in pharmaceutical manufacturing, including process and equipment validation.
Laboratory Support: Conduct lab-scale development experiments as needed to support process improvement and technology transfer.

Qualifications:

Education: Bachelor’s degree in Chemical Engineering, Biochemistry, Biotechnology, or a related scientific discipline.
Experience: 2+ years in a GMP or biopharmaceutical manufacturing environment, preferably in process development, technology transfer, or validation.
Skills:
Strong understanding of cGMP, process validation, and regulatory compliance.
Proficiency with Microsoft Word, Excel, and PowerPoint; experience with JMP or similar statistical analysis tools preferred.
Excellent organizational, analytical, and communication skills.
Ability to work collaboratively across teams and manage multiple priorities.

About the Company

Integrated Resources Inc. (IRI) is a professional staffing firm specializing in contract, consulting & full time positions in the area of Information Technology, Life Science and Allied Healthcare. Since its inception in 1996, IRI has continued to grow in size, opportunities, service and quality. Our expert team of highly trained counselors work hand in hand with every candidate and client forming a partnership of understanding and commitment. Know more