Advantage Technical
Location:
Cambridge, MA (with travel to Norton, MA as needed)
Schedule:
Monday–Friday, 9:00 AM – 5:00 PM | 100% Onsite
Position Overview A leading biopharmaceutical company is seeking a Manufacturing Technical Services Engineer II to support late‑stage and commercial drug product manufacturing. This role focuses on technology transfer, process validation, and continuous improvement initiatives to ensure robust, compliant, and efficient production of RNA‑based therapeutics. The position is lab‑based and involves collaboration across technical and operational teams.
Key Responsibilities
Support technology transfer, process scale‑up, and optimization activities at Contract Manufacturing Organizations (CMOs)
Assist with deviation assessments, change control documentation, CAPA development, and risk evaluations
Collect, analyze, and interpret process data; prepare technical summaries and reports
Contribute to process validation, investigations, and continuous improvement efforts
Author and revise process control documents; communicate updates to cross‑functional teams
Conduct lab experiments and small‑scale studies to support development and technical investigations
Collaborate with internal teams and external partners to ensure alignment on manufacturing strategies
Qualifications
Bachelor’s degree in Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or related scientific field
Minimum 2 years of hands‑on lab or GMP manufacturing experience (academic lab experience considered)
Experience with technology transfer and working with external manufacturing partners preferred
Proficiency in Microsoft Word, Excel, and PowerPoint; experience with JMP or similar statistical tools is a plus
Strong organizational, communication, and teamwork skills
Ability to lift up to 50 lbs and adhere to lab safety standards
Must be able to commute to both Cambridge and Norton, MA locations as needed
Preferred Experience
Background in engineering or process development
Experience executing lab investigations related to commercial manufacturing issues
Exposure to device testing or cross‑functional lab support
Familiarity with GMP environments and regulated manufacturing practices
Seniority Level Mid‑Senior level
Employment Type Contract
Industry Pharmaceutical Manufacturing
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Cambridge, MA (with travel to Norton, MA as needed)
Schedule:
Monday–Friday, 9:00 AM – 5:00 PM | 100% Onsite
Position Overview A leading biopharmaceutical company is seeking a Manufacturing Technical Services Engineer II to support late‑stage and commercial drug product manufacturing. This role focuses on technology transfer, process validation, and continuous improvement initiatives to ensure robust, compliant, and efficient production of RNA‑based therapeutics. The position is lab‑based and involves collaboration across technical and operational teams.
Key Responsibilities
Support technology transfer, process scale‑up, and optimization activities at Contract Manufacturing Organizations (CMOs)
Assist with deviation assessments, change control documentation, CAPA development, and risk evaluations
Collect, analyze, and interpret process data; prepare technical summaries and reports
Contribute to process validation, investigations, and continuous improvement efforts
Author and revise process control documents; communicate updates to cross‑functional teams
Conduct lab experiments and small‑scale studies to support development and technical investigations
Collaborate with internal teams and external partners to ensure alignment on manufacturing strategies
Qualifications
Bachelor’s degree in Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or related scientific field
Minimum 2 years of hands‑on lab or GMP manufacturing experience (academic lab experience considered)
Experience with technology transfer and working with external manufacturing partners preferred
Proficiency in Microsoft Word, Excel, and PowerPoint; experience with JMP or similar statistical tools is a plus
Strong organizational, communication, and teamwork skills
Ability to lift up to 50 lbs and adhere to lab safety standards
Must be able to commute to both Cambridge and Norton, MA locations as needed
Preferred Experience
Background in engineering or process development
Experience executing lab investigations related to commercial manufacturing issues
Exposure to device testing or cross‑functional lab support
Familiarity with GMP environments and regulated manufacturing practices
Seniority Level Mid‑Senior level
Employment Type Contract
Industry Pharmaceutical Manufacturing
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