What are the responsibilities and job description for the Manufacturing Technical Services Engineer II position at BioPharma Consulting JAD Group?
This position within the Manufacturing Technical Services (MTS) group will support regulatory dossier content and process analytics. The role involves data mining, verification, and analysis across the supply chain, ensuring compliance with regulatory requirements and supporting manufacturing oversight. The ideal candidate will have experience in pharmaceutical GMP manufacturing, strong technical writing skills, and the ability to manage large datasets from multiple sources.
Key Responsibilities:
- Conduct data mining and verification across the supply chain (starting materials, drug substance, and drug product) to support continued process verification, annual product quality reports, and manufacturing oversight.
- Verify regulatory dossier content against control strategies, master batch records, and other source documents.
- Collaborate cross-functionally with Validation, Quality, CMC, and other internal teams to ensure compliance and data integrity.
- Track and manage the status of data mining and verification for ongoing manufacturing.
- Compare manufacturing processes described in regulatory filings against batch records to ensure alignment.
- Maintain and manage a manufacturing data database, ensuring accuracy and compliance with reporting requirements.
- Perform data entry and verification, ensuring that manufacturing data is correctly documented and validated by different team members.
Qualifications & Experience:
- Education: Bachelor’s degree in Chemical Engineering, Chemistry, or a related field.
- Experience: Minimum 2 years in pharmaceutical GMP manufacturing and/or process development.
- Ability to organize and manage large datasets from multiple sources, including contract manufacturing organizations (CMOs).
- Familiarity with GMP, compliance, and data integrity standards.
- Strong technical writing and documentation skills.
- Experience with biotech manufacturing, regulatory processes, and quality control.
Top Skills for Success:
- Strong understanding of GMP and compliance within the pharmaceutical industry.
- Experience with manufacturing processes (e.g., batch records, SOPs).
- Ability to effectively manage and verify large datasets for regulatory and compliance purposes.
Work Schedule & Location:
- Schedule: Monday - Friday, 9:00 AM - 5:00 PM (No weekends).
- Work Arrangement: Hybrid; candidates can be based in Norton or Cambridge, with flexibility on which days they are onsite. Please indicate in the application notes if unable to travel between both locations.
