Location : Singapore
Duration : 9 months
Work Schedule: Full-time onsite presence
The Automation Engineer – Computer Systems Compliance is responsible for ensuring the ongoing compliance, reliability, and lifecycle management of computerized automation systems supporting sterile manufacturing operations. The role ensures that all systems are maintained in accordance with approved site procedures, global standards, current Good Manufacturing Practices (cGMP), Environmental Health and Safety (EHS) requirements, Data Integrity principles, engineering standards, and applicable regulatory requirements.
The incumbent supports the reliable operation of sterile manufacturing by executing scheduled Computer Systems Compliance activities, including user access management, alarm reviews, audit trail reviews, periodic system reviews, data backup and retrieval, and by managing deviations, change controls, and CAPAs. The role provides technical support for Rockwell Automation and Siemens PLC, HMI, SCADA, and virtualization (VM) applications, as well as computerized systems associated with formulation, washing, sterilization, aseptic filling, HVAC, fill-finish, and secondary packaging equipment, ensuring continuous compliance, system reliability, and operational excellence.
Responsibilities:
- Ensure the continued compliance of GMP computerized systems throughout their operational lifecycle in accordance with approved site procedures, global quality standards, and regulatory requirements.
- Execute routine Computer Systems Compliance (CSC) activities, including:
- User access management (creation, modification, periodic review, and deactivation of user accounts).
- Scheduled alarm reviews.
- Audit trail reviews in accordance with approved procedures.
- Computerized system periodic reviews.
- Data backup verification, restoration testing, and data retrieval activities.
- Review of system logs and security events, where applicable.
- Maintain complete, accurate, and compliant documentation for all Computer Systems Compliance activities.
- Initiate, investigate, and manage Deviations, Change Controls, and Corrective and Preventive Actions (CAPAs)related to computerized systems, ensuring timely implementation and effectiveness verification.
- Perform impact and risk assessments for changes affecting computerized systems and ensure compliance with change management procedures.
- Support regulatory inspections, internal audits, customer audits, and quality assessments by providing documentation and technical expertise related to computerized systems.
- Ensure compliance with Data Integrity requirements, including ALCOA+ principles, electronic records, electronic signatures, audit trail management, and security controls.
- Collaborate with Quality Assurance, Manufacturing, Validation, Engineering, IT, and Equipment Vendors to maintain the validated state of computerized systems.
- Participate in qualification, validation, and periodic review activities for GMP computerized systems in accordance with GAMP 5 and company validation standards.
- Monitor system performance and identify opportunities for continuous improvement, cybersecurity enhancements, and lifecycle optimization.
Equipment and Systems Supported:
- Provide Computer Systems Compliance support for sterile manufacturing process equipment, including but not limited to:
- IMA internal and external vial washers, Dehydrogenation and sterilization tunnels, Aseptic filling machines, Capping machines, Tray loading systems, HVAC and Building Management Systems (BMS), Steam sterilizers (Autoclaves), Parts washers, Formulation and compounding equipment, Fill-finish manufacturing equipment, Secondary packaging machines, associated PLC, HMI, SCADA, historian, and supervisory control systems supporting GMP manufacturing operations.
- Support commissioning, qualification, and validation of new computerized systems.
- Develop and review Validation Plans (VP), Risk Assessments, IQ/OQ protocols, Traceability Matrix, and Validation Summary Reports.
- Execute validation testing in accordance with GAMP 5, CSA principles, and site validation procedures.
- Review vendor documentation and Factory/Site Acceptance Test (FAT/SAT) documentation.
- Ensure computerized systems remain in a validated state throughout their lifecycle.
- Support implementation of cybersecurity controls including account management, patch coordination, antivirus compliance, backup validation, disaster recovery testing, and system hardening for GMP automation systems.
Minimum Requirements / Qualifications
Education
- Bachelor's degree in Automation Engineering, Electrical & Electronics Engineering, Instrumentation Engineering, Computer Engineering, or a related engineering discipline.
Experience
- 5 to 8 years of proven experience in the maintenance of process equipment, preferably in a Pharma manufacturing facility.
- Hands-on experience with PLC/SCADA sterile manufacturing equipment is required.
- Good understanding of equipment validation, GMP requirements, and maintenance practices in a regulated manufacturing environment. .
- Experience with Maximo, TrackWise, and Kneat is an added advantage.
Competencies
- Able to work effectively in a fast-paced and highly regulated environment.
- Strong ability to plan, schedule, organize, prioritize, and coordinate maintenance and project activities.
- Good understanding of production processes and related validation, GMP, and compliance requirements.
- Strong troubleshooting skills with good knowledge of Root Cause Analysis tools and problem-solving methodologies.
- Rockwell FactoryTalk ,Siemens TIA Portal, Wincc, Historian systems, Active Directory.
- Good communication, coordination, and documentation skills.
WHO WE ARE
PQE Group is a women-owned, ISO 9001:2015 and ISO/IEC 27001:2022 certified technology solutions and compliance consulting company, offering comprehensive quality solutions for GCP, GLP, GMP, GVP, and GDP areas in the Life Sciences industry. With over 2,000 employees (40% of whom are women) across 40+ offices worldwide, we bring together more than 50 nationalities and operate in 25+ languages.
We are dedicated to creating value for our customers by leveraging our multidisciplinary teams and expertise, enabling them to achieve and maintain compliance with the latest regulations while optimizing processes and ensuring data integrity.
Our commitment to quality, security and innovation, backed by international certifications and decades of experience, allows us to provide scalable, tailored solutions that meet the evolving needs of the life sciences sector.
WHAT WE DO
Since 1998, PQE Group has been delivering turnkey quality solutions across the entire product qualitylifecycle, focusing on offering cost-effectiveness without compromising quality. Our broad service portfolio and extensive experience have made us the trusted partner for global corporations, as well as small and medium-sized enterprises. To date, we have completed over 25,000 projects worldwide for 1,400+ clients in the pharmaceutical, medical device, SaMD, biotech, veterinary and other life science related sub-industries.
WHY US?
Our proven combination of expertise in project management, wide-ranging services, and exceptionalcost-effectiveness makes PQE Group a valuable partner for businesses of all sizes. We help our clients achieve compliance, ensuring that our solutions drive success.
WHERE WE’RE GOING
At PQE Group, we are committed to fostering positive change in the communities and environments where we operate. Through our corporate social responsibility goals, we promote sustainable development, gender equality, environmental protection, and health and safety initiatives. Our partnerships with programs and charity organizations globally reflect our dedication to driving social and environmental impact.
WORKING AT PQE GROUP
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills andinteract with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.