MES Engineer / Quality Engineer (Pharma)

ORKA LIFESCIENCE PARTNERS PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

ORKA LIFESCIENCE PARTNERS PTE. LTD. seeks an MES specialist to review and approve electronic batch records, elogs and MES-related documentation in biopharmaceutical manufacturing environments.

You will support qualification/validation activities, author test scripts, and help maintain MES recipes, workflows and dashboards. Strong knowledge of regulatory requirements (21 CFR Part 11, Annex 11) is preferred.

Qualifications

• 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 MES (e.g., Syncade, PAS-X, OpCenter EX Pharma, POMSnet, PharmaSuite).
• Preferably with Quality role experience.

Responsibilities

• Review and approve electronic batch records, worksheets and elog designed for MES implementation.
• Review and approve documentation for MES integration with ERP, PLM, LIMS and equipment.
• Support qualification/validation activities including authoring and executing test scripts.
• Participate in development and maintenance of electronic batch records, process instructions, recipes and workflows.
• Participate in development and maintenance of reports, dashboards and visualizations for manufacturing performance.
• Provide technical support and training to end-users.
• Support project and system change management.
• Contribute to continuous improvement of MES systems and processes.
• Maintain updated system documentation.
• Identify gaps in system administration, quality and compliance, and drive improvements.

Skills

MES knowledge

Documentation

Recipe authoring

Installation & troubleshooting

Validation support

Education

Bachelor’s degree in Life Sciences/Engineering

Tools

Syncade

PAS-X

OpCenter EX Pharma

POMSnet

PharmaSuite

Job description

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 possessingIntelligence, Resourcefulness, Loyalty and Teamworkcharacteristics.


• 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.