MES Engineer / Quality Engineer (Pharma)

Key Responsibilities:

• 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.

Requirements:

• 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).

Why Join ORKA:

• 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.