Computer System Validation Consultant

at  PHARMENG TECHNOLOGY PTE LTD

We are seeking an experienced Computer System Validation Consultant to help drive our solution-based business model and take our designs to the next level. Our consultants have the chance to work hands-on with several business divisions to design, develop, test industry-leading solutions for our clients—both nationally and internationally. Our ideal candidate is a creative thinker who shares our passion for making people’s lives easier.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in business/technical field or equivalent education/experience.
• 3 to 5 years of experience in Computer Systems Validation within the pharmaceutical/biotechnology GMP environment, involving IOQ/PQ authoring and execution, traceability matrices, and risk assessments.
• Prior experience with Takeda and familiarity with Emerson Delta V software is a plus.
• Strong technical skills in configuring various Laboratory systems, including Standalone instruments like Mass Spec, IC, Matersizer, UV, FTIR, DSC, etc.
• Understanding and ability to configure TCP/IP network connectivity between systems.
• Excellent knowledge of Desktop Operating systems, including Windows 2000, Windows 7, and Windows 10, covering permissions, user configuration, and peripheral device connections.
• Proficient in drive mapping, logon scripts, and analyzing system logs.
• Good understanding of Active Directory, Domain permissions, and LDAP.
• Advanced understanding of data system security for safeguarding electronic assets, intellectual property, and privacy.
• Experience in developing and implementing complex data exchange processes between information systems.
• Proficient in creating/developing moderately to complex functional requirements mapping to an Information System based on user needs.
• Ability to independently identify compliance risks and escalate when necessary.
• Self-starter with strong team communication skills.
• Proven ability to lead a team.

• Create and refine validation protocols for GxP critical reports, focusing on Computerized Equipment Validation within the QC lab.
• Configure static Master Data for validated/GMP-compliant LabWare LIMS (version 6), specifically emphasizing Computerized Equipment.
• Actively participate in executing, reviewing, and approving validation protocols for Computerized Equipment.
• Generate Change requests and IT tickets tailored for report validation of Computerized Equipment.
• Validate business intelligence reports, showcasing expertise in necessary tests for qualification.
• Review and draft SOPs, specifically for Computer System Validation Projects, with a focus on Computerized Equipment.
• Develop documentation for Computer System Validation projects, including URS, FRS, FRA, HLCCD, etc.
• Address and resolve issues during Computerized Equipment validation, including deviations and change controls.
• Ensure compliance of computerized systems, especially LabWare LIMS and other Computerized Equipment, with relevant regulations.
• Draft templates for High-Level Risk Assessments, User Requirements Specification, Validation Plans, and Validation Summary Reports, emphasizing Computerized Equipment Validation.
• Act as a liaison between Quality Assurance and the project team, ensuring strict compliance with regulations for GxP software and Computerized Equipment.
• Manage planning and execution of Computerized Equipment Validation projects within established timelines and budgets.
• Coordinate effectively with teams, clients, and stakeholders, specifically for Computerized Equipment Validation.
• Oversee day-to-day operations of Computerized Equipment Validation projects.
• Ensure completeness, review, approval, and proper storage of project documents related to Computerized Equipment Validation.
• Keep the Computerized Equipment Validation team well-informed of project changes.Experience with Kneat and validation of around 15 computerized systems (LCE), excluding Electrical Equipment (EE).