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Industry: Pharmaceutical / Medical Devices

Overview:

We are looking for a skilled Manufacturing System Engineer to join our team. The ideal candidate will have a strong background in industrial automation and computerized software validation, with experience in pharmaceutical manufacturing environments. This role is 100% remote, providing an exciting opportunity to work on innovative projects while collaborating with clients and teams across the globe.

Key Responsibilities:

• Industrial Automation:

  • Design, implement, and maintain control systems, including PLC, DCS, SCADA, or MES.

  • Collaborate with cross-functional teams to ensure system integration and performance.

• Software Validation:

  • Conduct computerized software validation in compliance with regulatory standards.

  • Document validation processes and ensure all software systems meet quality requirements.

• Programming & Database Analysis:

  • Utilize object-oriented programming languages to develop and enhance manufacturing software solutions.

  • Analyze and optimize relational databases to support operational needs.

• Requirements Gathering:

  • Identify, gather, and document software requirements, gaps, and potential enhancements.

  • Work closely with stakeholders to understand their needs and translate them into technical specifications.

• Integration with External Applications:

  • Manage interfaces with ERP, LIMS, PLN, and/or OPC systems to ensure seamless data flow.

  • Collaborate with IT and other departments to ensure system compatibility and efficiency.

• Factory Floor Experience:

  • Leverage experience in pharmaceutical manufacturing (drug substances, drug products, or cell and gene therapy) to provide insights and support for client projects.

  • Share best practices and contribute to process improvement initiatives in manufacturing environments.

Required Qualifications:

• Language: Fluent in English

• Education:

  • Bachelor’s degree in Engineering, Computer Science, or a related field.

• Experience:

  • 3 to 5 years of experience in industrial automation (PLC, DCS, SCADA, or MES programming).

  • 3 to 5 years of experience in computerized software validation.

  • 1 to 3 years of experience in an object-oriented programming language.

  • 1 to 3 years of experience in analyzing relational databases.

  • 3 to 5 years of factory floor experience in pharmaceutical manufacturing or medical devices.

• Skills:

  • Strong understanding of manufacturing processes, especially in pharmaceuticals and medical devices.

  • Excellent analytical and problem-solving skills.

  • Effective communication and collaboration abilities in a remote work environment.

  • Knowledge of regulatory requirements and industry best practices.

• Availability to travel may be required

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