What are the responsibilities and job description for the Manufacturing Technical Services Engineer II position at Integrated Resources, Inc ( IRI )?
Hybrid, open to the days they would go onsite each week .
Can sit in NORTON or CAMBRIDGE
This position within the Manufacturing Technical Services group will support regulatory dossier content as well as process analytics. Responsibilities include:
- Data mining and verification across our supply chain (starting materials, drug substance, and drug product) to support continued process verification, annual product quality reports, and general manufacturing oversight through data analysis.
- Verification of regulatory dossier content aProductst control strategies, master batch records, and other source documents.
- Cross-functional collaboration with Validation, Quality, CMC, and other internal teams.
- Track and manage data mining/verification status for ongoing manufacturing.
Qualifications/experience:
BS with minimum 2 years’ experience in pharmaceutical GMP manufacturing and/or process development
Degree in chemical engineering, chemistry, or related field
Ability to organize and manage large sets of data from multiple sources/CMOs
Familiar with general GMP, compliance, and data integrity standards
Strong technical writing skills
