MES Engineer / Quality Engineer (Pharma)

• Review and approve electronic batch record (eBR), worksheets and electronic logbook (elog) designed, configured and deployed during MES implementation in the pharmaceutical manufacturing plants.
• Review and approve documentations for MES integration with other enterprise systems (e.g., ERP, PLM, LIMS) and equipment.
• Support qualification / validation activities including authoring and executing test scripts and where possible, support validation strategy development.
• Participate in the development and maintenance electronic batch record, process instructions, recipes, workflows, electronic logbooks, etc.
• Participate in the development and maintenance of reports, dashboards, and visualizations to provide insights into manufacturing performance.
• Provide technical support and training to end-users.
• Support project and system change management.
• Contribute to the continuous improvement of the MES system and related processes.
• Maintain updated system documentations.
• Identify gaps in system administration, management, quality and compliance, and drive operational improvement processes.

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.
• Have worked for at least 2 years in the pharmaceutical industry.
• Understand the manufacturing processes and equipment in the biopharmaceutical industry.
• Have technical understanding of the recipe / workflow / process instruction in one Manufacturing Execution System (MES) (e.g., Syncade, PAS-X, OpCenter EX Pharma, POMSnet, PharmaSuite).
• Preferably with Quality role experience.
• Preferably with hands-on recipe authoring experience.
• Preferably having supported installation, administration and troubleshooting of computer systems and servers.
• Understand computerised system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11) and industry best practice (e.g., ISA 88, GAMP5).

• Work that Matters: Support clients bringing innovative and life saving solutions to the population.
• Career Development: Build a consulting career in a professional consulting company with Life Sciences focus. Exposure with mutliple MES solutions.
• Professional Environment: Work with similar professionals possessing Intelligence, Resourcefulness, Loyalty and Teamwork characteristics.
• Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.

Skills

DCS, MES Software, Personal Chef Services, Operation Qualification, Pharmaceutical Manufacturing, Quality Assurance, Process Validation, Computerised Systems Validation, Installation Qualification, Batch Processing, System Validation, Database Installation, Life Sciences, Manufacturing Execution Systems, Performance Qualification