Process Engineer for Pharmaceutical Manufacturing

4 weeks ago


Rahway, New Jersey, United States Insight Global Full time

We are seeking a skilled Process Engineer to support our CMC digitization initiative for a leading pharmaceutical company in Ireland.

The ideal candidate will have extensive experience working in pharmaceutical manufacturing environments, experience with digital transformation, and knowledge of process knowledge management systems (PKM).

Technical experience with Delta V, SAP, and MES systems, as well as expertise with pharmaceutical analytical instruments, tech transfer, and data management, is a requirement.

This role will be critical in optimizing our manufacturing processes through digital knowledge transfer and automation, ensuring efficiency, compliance, and data integrity.

Key Responsibilities:

  • System Integration and Automation: Design, implement, and maintain automation systems using Delta V, SAP, and MES to support the CMC digitization initiative.
  • Data Management: Develop and implement data management strategies to ensure accurate, secure, and accessible data across all digitized processes.
  • Project Collaboration: Work closely with cross-functional teams, including R&D, Quality, Regulatory Affairs, IT, and Manufacturing, to ensure alignment and support for automation initiatives.
  • Compliance and Validation: Ensure all automation and digitization efforts comply with regulatory standards and quality requirements.

Requirements:

  • Minimum of 5 years of experience in process engineering within the pharmaceutical or biotechnology industry.
  • Proven experience with digital transformation projects in a manufacturing environment.
  • Knowledge/Familiarity with process knowledge management systems (PKM).
  • Expertise in Delta V, SAP, and MES systems, with a proven track record of successful system integration and automation.
  • Strong knowledge of tech transfer processes and data management strategies in a pharmaceutical context.
  • Knowledge of international manufacturing and regulatory standards related to pharmaceutical products and substances.
  • Large molecule pharmaceutical process engineering experience.
  • Bachelor's degree in Chemical Engineering, or a related field.

Benefits:

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching.


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