Manufacturing Technical Services Engineer II
New Today
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
Pay ranges between $38-41/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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- Location:
- Norton, MA, United States
- Category:
- Architecture And Engineering Occupations