Senior/ Consultant (Lab/Enterprise IT Computer System Validation) [Pharma/Biotech]

NNIT Singapore; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A leading life sciences consulting firm in Singapore seeks a Senior/Consultant in IT CSV. You will ensure the secure operation and qualification of laboratory applications while coordinating with stakeholders. The ideal candidate has IT CSV experience in pharmaceutical settings and holds a relevant degree. This full-time on-site role offers opportunities for career advancement within a dynamic and supportive environment.

Benefits

Impactful Projects

Professional Environment

Leadership Opportunities

Career Development

Training & Mentoring

Qualifications

• 5+ years of IT CSV experience in a pharmaceutical or GMP environment.
• Experience in paperless validation system and document management system.
• Proficient in executing cybersecurity threat response and compliance audits.

Responsibilities

• Ensure secure operation, integration, and qualification of laboratory applications.
• Work closely with key stakeholders on-site to drive project success.
• Manage and coordinate with stakeholders for task reviews.

Skills

Laboratory Applications and Configuration

Data Migration and Integrity

Networking and IT Systems

System Maintenance and Imaging

Cybersecurity and Threat Response

Data Integrity and Compliance

Stakeholder Coordination

Cross-Functional Team Support

Documentation

Commissioning and Qualification

Education

Bachelor’s or Master’s degree in Engineering, Control System/Computer Science/Information Security

Job description

About Us

Headquartered in Denmark, NNIT Singapore Pte Ltd is a rapidly expanding leader in life science consulting, delivering innovative solutions across Singapore and the broader Asian region since 2011. We provide comprehensive, end-to-end services tailored to life science clients, covering every aspect of the value chain-from laboratory environments and clinical operations to regulatory affairs, manufacturing, and supply chain management. Guided by our core values-Open & Honest, Conscience Driven, and Value Adding-our approach ensures that these principles are reflected in every interaction. With a dedicated team of 1,700 consultants across Europe, Asia, and the USA, we are committed to supporting our clients in bringing vital medicinal products to patients.

Role Overview

NNIT is seeking experienced professionals from the life sciences industry for a full-time on-site role at our client locations in Tuas, Singapore. As a Senior/Consultant in IT CSV you will be responsible for ensuring secure operation, integration, and qualification of laboratory applications for our clients.

In this role, you will report to your Line Manager and work closely with key stakeholders on-site. Your expertise and proactive approach will be crucial in driving project success and delivering high-quality service.

Key Competencies

Laboratory Applications and Configuration:

• Proficient in handling and configuring laboratory applications such as Tiamo, HPLC, Endoscan, TOC, and SOLOVPE.

Data Migration and Integrity:

• Skilled in executing data migration tasks, including backup, and archiving processes, ensuring data security and compliance.

Networking and IT Systems:

• Basic understanding of network systems, including firewalls, DNS, IP management, and cable patching.
• Experienced in software configurations, including PC setups per in-house IT requirements and remote desktop tools like Dameware.

System Maintenance and Imaging:

• Skilled in PC imaging using tools such as Acronis or Macrium to ensure efficient system recovery and deployment.

Cybersecurity and Threat Response:

• Competent in identifying and responding to cybersecurity threats, collaborating with Cybersecurity teams to address potential security breaches or lockouts.

Data Integrity and Compliance:

• Experienced in executing job plans such as audit trail reviews, user access reviews, manual password resets, and critical settings verification in line with Data Integrity Assessments (DIA) or security assessments.

Stakeholder Coordination:

• Skilled in managing and coordinating with stakeholders for task reviews and successful project execution.

Cross-Functional Team Support:

• Adept at supporting cross-functional teams, fostering collaboration, and achieving shared objectives across technical and operational domains.

Documentation:

• Draft and review design and qualification
• Experience in paperless validation system and document management system

Commissioning and Qualification:

• Execution experience
• Knowledge on 21CFR Part 11 and GAMP 5 categories

Essential Qualifications

• Experience: IT CSV experience in a pharmaceutical or GMP environment

• Education: Bachelor’s or Master’s degree in Engineering, Control System / Computer Science / Information Security, or a related field.

Valuable Experience

• Incident Management: Conduct root cause analysis and contribute to post-incident reviews, ensuring corrective actions and improvements in security measures.

• Troubleshooting: Resolve complex technical issues while maintaining compliance with CSV practices.

What We Offer

• Impactful Projects: Consulting roles with international healthcare clients on strategically significant projects.

• Professional Environment: Work within a motivated team in a professional consultancy setting.

• Leadership Opportunities: Take on leadership roles and contribute to shaping our organization.

• Career Development: Excellent opportunities for career advancement within a leading consulting firm.

• Training & Mentoring: Structured training programs and peer mentoring to support your professional growth.

If you’re ready to make a significant impact in the life sciences field and advance your career with a rapidly growing firm, we invite you to apply for this exciting opportunity.