Job Description

Manufacturing Technical Services Engineer II - Contract - Cambridge, MA,

Proclinical is seeking a Manufacturing Technical Services Engineer II to join our client's team in Cambridge, MA.

Primary Responsibilities:

The successful candidate will focus on supporting regulatory dossier content and process analytics within the manufacturing technical services group. Your expertise will be crucial in ensuring data integrity and compliance across our supply chain.

Skills & Requirements:

• Degree in chemical engineering, chemistry, or a related field.
• Proficient in organizing and managing large datasets from multiple sources.
• Familiarity with GMP, compliance, and data integrity standards.
• Strong technical writing skills.

The Manufacturing Technical Services Engineer II's responsibilities will be:

• Conduct data mining and verification for starting materials, drug substances, and drug products.
• Support continued process verification and annual product quality reports through data analysis.
• Verify regulatory dossier content against control strategies and master batch records.
• Collaborate with cross-functional teams including Validation, Quality, and CMC.
• Track and manage the status of data mining and verification for ongoing manufacturing processes.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at [email protected]

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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