Manufacturing Engineering Technician

2 days ago

Florence, South Carolina, United States Thermo Fisher Scientific Full time
Job Summary

We are seeking a highly skilled Manufacturing Engineering Technician to join our team at Thermo Fisher Scientific. As a key member of our manufacturing operations, you will play a critical role in ensuring the smooth execution of our production processes.

Key Responsibilities
  • Administer batch records, including SAP confirmations and batch record review, to ensure compliance with regulatory and cGMP guidelines.
  • Handle change requests from submission to close-out, ensuring implemented changes meet objectives.
  • Enter and complete deviation assessments to identify and address potential issues.
  • Assist in the resolution of manufacturing discrepancies and product investigations by evaluating data and defining corrective and preventative actions.
  • Support the implementation of engineering projects, including commissioning and validation-related documents.
  • Facilitate cleaning execution activities to minimize equipment downtime while adhering to regulatory compliance.
  • Plan and schedule cleaning solvent deliveries, disposal, and reconfiguration, as well as procedure training and execution.
  • Perform manufacturing area maintenance management, including submission of notifications and follow-up to ensure accurate completion of work.
  • Issue and audit work permits to ensure compliance and safety procedures.
  • Create and update Manufacturing Batch Records (MBR) as needed.
  • Provide technical feedback to solve process and equipment problems and support continuous improvement projects.
  • Participate in and provide technical information to manufacturing Quality Risk Assessments (QRAs), Root Cause Analysis (RCA), and Process Hazard Analysis (PHAs).
  • Evaluate automation changes and verify automation downloads.
  • Ensure proper inventory management of raw materials and operating supplies.
  • Assist with cycle counting and physical inventory requirements, performing inventory reconciliation as needed.
  • Provide Instructor-Led Training on procedures, techniques, and processes.
  • Administer, document, and maintain Patheon Quality Systems conformance to regulatory requirements and company policies.
  • Perform lubrication walk-downs and document updates in Patheon's Quality Systems.
  • Review as-built P&IDs and prepare equipment pressure test packages.
Requirements

We are looking for a candidate with a High School Diploma or equivalent and successful completion of Phases I-IV of the Process Tech Training Program or equivalent related work experience. A minimum of 2 years of related experience is required, with extensive knowledge of PCR-2 automation systems and concepts, chemical manufacturing equipment, and pharmaceutical cGMP operations.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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