Advanced Manufacturing Tech Solutions (AMTSOL) -
We are Delivering Innovation through Technology for Life Science Manufacturing. With focus on Pharma 4.0 and Digitalization helping regulated manufacturers to increase speed to market and operating efficiency. Life Science Manufacturing Systems expert with end to end implementation and support capability of GMP Manufacturing systems and solutions for Automation Manufacturing Execution Systems (MES) OT Networking and Digital Technologies.
Location: Singapore
Role - Werum PAS-X System Administrator
Job Summary
We are seeking an experienced Werum PAS-X System Administrator to manage maintain and support the Werum PAS-X MES platform within a regulated pharmaceutical manufacturing environment. The role involves system administration configuration management validation support and ensuring compliance with GMP and regulatory requirements.
Key Responsibilities
-
Administer and maintain Werum PAS-X MES in a GMP-regulated manufacturing environment.
-
Perform system installation configuration upgrades patching and performance monitoring.
-
Manage user access roles and security in compliance with 21 CFR Part 11 requirements.
-
Provide L2/L3 support for MES-related issues and coordinate with global IT teams and vendors.
-
Support recipe management master data management and electronic batch records (EBR).
-
Ensure system availability data integrity backup and disaster recovery processes.
-
Participate in system validation activities (IQ/OQ/PQ) and documentation as per GAMP5 guidelines.
-
Collaborate with manufacturing quality automation and IT teams for system enhancements.
-
Manage change control incident management and deviation handling processes.
-
Support integration with ERP (e.g. SAP) LIMS SCADA and other automation systems.
-
Maintain compliance with GMP FDA EMA and other regulatory standards.
Required Qualifications
-
Bachelors degree in Engineering Computer Science or related field.
-
5 years of experience in MES administration within pharmaceutical manufacturing.
-
Strong hands-on experience with Werum PAS-X system configuration and administration.
-
Good understanding of GMP GAMP5 21 CFR Part 11 Annex 11.
-
Experience supporting validated systems in regulated environments.
-
Knowledge of SQL databases Windows Server environments and networking basics.
Preferred Skills
-
Experience with PAS-X 3.x / 3.2 / 3.3 versions.
-
SAP integration knowledge.
-
Understanding of ISA-95 and ISA-88 standards.
-
Experience in serialization track & trace (optional).
-
Strong documentation and communication skills.
Soft Skills
-
Strong problem-solving and analytical skills.
-
Ability to work in cross-functional and global teams.
-
Detail-oriented with strong compliance mindset.
-
Ability to manage multiple priorities in a fast-paced environment
Advanced Manufacturing Tech Solutions (AMTSOL) - We are Delivering Innovation through Technology for Life Science Manufacturing. With focus on Pharma 4.0 and Digitalization helping regulated manufacturers to increase speed to market and operating efficiency. Life Science Manufacturing Systems expert...
Advanced Manufacturing Tech Solutions (AMTSOL) -
We are Delivering Innovation through Technology for Life Science Manufacturing. With focus on Pharma 4.0 and Digitalization helping regulated manufacturers to increase speed to market and operating efficiency. Life Science Manufacturing Systems expert with end to end implementation and support capability of GMP Manufacturing systems and solutions for Automation Manufacturing Execution Systems (MES) OT Networking and Digital Technologies.
Location: Singapore
Role - Werum PAS-X System Administrator
Job Summary
We are seeking an experienced Werum PAS-X System Administrator to manage maintain and support the Werum PAS-X MES platform within a regulated pharmaceutical manufacturing environment. The role involves system administration configuration management validation support and ensuring compliance with GMP and regulatory requirements.
Key Responsibilities
-
Administer and maintain Werum PAS-X MES in a GMP-regulated manufacturing environment.
-
Perform system installation configuration upgrades patching and performance monitoring.
-
Manage user access roles and security in compliance with 21 CFR Part 11 requirements.
-
Provide L2/L3 support for MES-related issues and coordinate with global IT teams and vendors.
-
Support recipe management master data management and electronic batch records (EBR).
-
Ensure system availability data integrity backup and disaster recovery processes.
-
Participate in system validation activities (IQ/OQ/PQ) and documentation as per GAMP5 guidelines.
-
Collaborate with manufacturing quality automation and IT teams for system enhancements.
-
Manage change control incident management and deviation handling processes.
-
Support integration with ERP (e.g. SAP) LIMS SCADA and other automation systems.
-
Maintain compliance with GMP FDA EMA and other regulatory standards.
Required Qualifications
-
Bachelors degree in Engineering Computer Science or related field.
-
5 years of experience in MES administration within pharmaceutical manufacturing.
-
Strong hands-on experience with Werum PAS-X system configuration and administration.
-
Good understanding of GMP GAMP5 21 CFR Part 11 Annex 11.
-
Experience supporting validated systems in regulated environments.
-
Knowledge of SQL databases Windows Server environments and networking basics.
Preferred Skills
-
Experience with PAS-X 3.x / 3.2 / 3.3 versions.
-
SAP integration knowledge.
-
Understanding of ISA-95 and ISA-88 standards.
-
Experience in serialization track & trace (optional).
-
Strong documentation and communication skills.
Soft Skills
-
Strong problem-solving and analytical skills.
-
Ability to work in cross-functional and global teams.
-
Detail-oriented with strong compliance mindset.
-
Ability to manage multiple priorities in a fast-paced environment
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