Pharmaceutical Validation Specialist

3 weeks ago


Fall River, Massachusetts, United States Staffworthy Full time
About the Job

Job Title: Validation Engineer

Location: Fall River, MA

This role is responsible for performing validation activities and reviewing specifications for facilities, utilities, manufacturing, and laboratory equipment in a pharmaceutical setting. The Validation Engineer will partner with cross-functional team members to ensure compliance and operational success through user-focused documentation.

Key Responsibilities
  • Design, review, and approve protocols for equipment and processes to produce pharmaceutical drug products meeting internal, external, and regulatory guidelines.
  • Maintain facilities per cGMP and regulatory requirements.
  • Introduce new SOPs, equipment, and instruments to improve the work environment by safety and quality points of view.
  • Compile and maintain records of validation documentation and electrical schematics.
  • Programming, troubleshooting, and modifying PLC programs for optimum efficiency and ideal operation of production machinery.
  • Review the design, installation, operational, and product qualification of operations machinery.
  • Assist in operations, validation, and electrical engineering plans to ensure adherence to design specifications and compliance with applicable electrical codes and standards.
  • Handle troubleshooting, preventive, and breakdown maintenance of manufacturing equipment for Encapsulation, Granulation, Compression, Coating, and Packaging operations.
  • Manage quarterly preventive maintenance and breakdowns of facility equipment, including HVAC, Boiler, Chiller, Air Compressor, and Electrical Panels.
  • Work closely with Quality Assurance and Validation Engineering teams to complete qualification in a timely manner.
  • Work closely with external electrical/instrumentation service agencies on upgrading existing systems and troubleshooting errors and breakdowns.
  • Ensure all process improvement projects are completed on time and within budget.

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