Deskripsi Pekerjaan
Are you a detail-oriented engineer with a passion for driving operational excellence in highly regulated environments? Smarthire by SEEK is partnering with a leading pharmaceutical and medical device organization to appoint a Manufacturing Systems Engineer (MES). This role is pivotal in ensuring that our client's digital manufacturing ecosystem is robust, compliant, and optimized for high-speed production.
As the Manufacturing Systems Engineer, you will serve as the technical bridge between IT infrastructure and shop-floor operations. You will be responsible for the implementation, maintenance, and continuous improvement of Manufacturing Execution Systems (MES). The ideal candidate will possess a deep understanding of GAMP 5, 21 CFR Part 11, and the intricacies of automation in the medical device sector. If you are ready to make a significant impact on life-saving production processes while leveraging the latest in Industry 4.0 technology, we want to hear from you.
Tanggung Jawab
- Lead the deployment, configuration, and lifecycle management of MES solutions across multiple manufacturing lines.
- Ensure full compliance with global regulatory standards including FDA 21 CFR Part 11 and EU Annex 11.
- Collaborate with cross-functional teams (Production, Quality, IT) to map business processes into digital workflows.
- Troubleshoot and resolve complex system integration issues between ERP, MES, and PLC/SCADA systems.
- Manage system validation activities (IQ/OQ/PQ) and ensure all documentation meets stringent quality audit requirements.
- Drive continuous improvement initiatives to enhance data integrity, system throughput, and operational efficiency.
- Provide technical training and support to shop-floor operators and supervisors to ensure seamless system adoption.
Kualifikasi
- Bachelor’s degree in Automation Engineering, Computer Science, Chemical Engineering, or a related field.
- Minimum 3-5 years of experience in MES implementation within the Pharma, Biotech, or Medical Device industry.
- In-depth knowledge of GAMP 5, cGMP, and validation methodologies in a regulated environment.
- Hands-on experience with leading MES platforms (e.g., Werum PAS-X, Rockwell FactoryTalk, or SAP ME).
- Proficiency in SQL, scripting, or data visualization tools for reporting and process analysis.
- Strong problem-solving skills with the ability to translate complex technical requirements into user-friendly digital solutions.
- Exceptional communication skills and the ability to work effectively in a high-pressure manufacturing environment.