Strategy & Consulting - Global Network - Industry X - Manufacturing System Engineer Consultant
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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.