What are the responsibilities and job description for the Manufacturing Technical Services Engineer position at Integrated Resources, Inc ( IRI )?
Schedule M-F 9-5pm
Skills - Bio tech manufacturing regulatory, Technical in BioTech, Quality Control
hybrid, open to the days they would go onsite each week
Can sit in NORTON or CAMBRIDGE
Summary:
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 against 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
Salary : $40 - $44
