What are the responsibilities and job description for the Manufacturing Technical Services Engineer II position at Careers Integrated Resources Inc?
Job Title: Manufacturing Technical Services Specialist
Location: Hybrid – Open to sitting in Norton or Cambridge
Schedule: Schedule M-F 9-5pm
Must have Skills
- Bio tech manufacturing
- Regulatory,
- Technical in BioTech, Quality Control.
Role Overview:
This position within the Manufacturing Technical Services group will support regulatory dossier content and process analytics. The role involves data mining, verification, and cross-functional collaboration to ensure manufacturing oversight and compliance.
Key Responsibilities:
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Perform data mining and verification across the supply chain, including starting materials, drug substance, and drug product.
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Support continued process verification, annual product quality reports, and manufacturing oversight through data analysis.
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Verify regulatory dossier content against control strategies, master batch records, and other source documents.
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Collaborate with Validation, Quality, CMC, and other internal teams to ensure compliance and data integrity.
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Track and manage data mining/verification status for ongoing manufacturing processes.
Qualifications & Skills:
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Education: BS in Chemical Engineering, Chemistry, or related field.
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Experience: Minimum of 2 years in pharmaceutical GMP manufacturing and/or process development.
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Strong understanding of biotech manufacturing, regulatory processes, and quality control.
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Ability to organize and manage large data sets from multiple sources/CMOs.
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Familiarity with GMP, compliance, and data integrity standards.
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Strong technical writing skills for documentation and regulatory support.
