Senior/Consultant (Digital Manufacturing/MES/Computer System Validation) [Pharma/Biotech]

-; Singapore; On-site; SGD 75,000 - 110,000; Full time

Job summary

NNIT is hiring a Senior/Consultant in Digital Manufacturing for roles focusing on validation of computer systems and applications in the life sciences sector. This full-time position requires a minimum of 3 years' experience in related environments, offering opportunities to work on impactful projects internationally and develop professionally within a motivated team.

Benefits

Impactful Projects

Professional Environment

Leadership Opportunities

Career Development

Training & Mentoring

Qualifications

• Over 3 years in a pharmaceutical or GMP environment.
• Experience with GxP validation processes.
• Good understanding of FDA regulations.

Responsibilities

• Support clients through the project lifecycle for system validation.
• Ensure compliance with FDA and global regulatory standards.
• Document and manage change control processes.

Skills

Validation Methodology

Regulatory Knowledge

Technical Proficiency

Education

Bachelor's degree in Engineering or Science

Tools

Manufacturing Execution System (MES)

GxP Computer Systems

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 Digital Manufacturing, CSV, you will be supporting our clients through the entire project lifecycle in ensuring all computer systems and software applications are validated according to industry standards, regulatory, and client requirements.

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

• Validation Methodology: Expertise in performing and documenting qualification/validation activities such as IQ, OQ, PQ, and ensuring systems meet predefined requirements.

• Regulatory Knowledge: Familiarity with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other global regulations to ensure compliance in system validation processes.

• Technical Proficiency: Strong understanding of software and hardware systems used in pharma, including troubleshooting and maintaining validated systems.

Essential Qualifications

• Experience: Over 3 years in a pharmaceutical or GMP environment, with expertise in either:

1. GxP Computer Systems Validation in laboratory equipment or manufacturing equipment
2. Manufacturing Execution System (MES) (e.g., Emerson Syncade, Körber/ Werum PAS-X, Siemens Opcenter Execution Pharma, POMSnet, Rockwell PharmaSuite)
3. Data management or integration technologies (e.g OSI PI)

Fresh graduates, preferably with internship in pharmaceutical industry, and those with lesser experience may be considered for Junior roles.

• Education: at least Bachelor's degree in Engineering or Science

• Regulatory Knowledge: Good understanding of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other global regulations

Valuable Experience

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

• Change Management: Experience in managing the change control process, including documenting, assessing, and implementing changes to validated systems while ensuring compliance.

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 contribut 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.