Senior/Consultant (Commissioning, Qualification, Validation) Pharma/Biotech

Roles & Responsibilities

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 full-time, on-site roles at our client locations in Tuas, Singapore. As a Senior/Consultant in Manufacturing Science & Technology, you will be instrumental in supporting our clients through the entire project lifecycle. You will be responsible for ensuring that projects adhere to industry best practices and regulatory standards, managing execution, delivery, and documentation effectively.

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

Project Management: Anticipate and address issues proactively, planning resolutions within established timelines.

Effective Communication: Provide clear and concise correspondence with clients and team members.

Technical Writing: Produce detailed and accurate project plans, risk assessments, protocols, and reports with minimal revisions.

Document Management: Oversee the complete document lifecycle from creation and review to archival.

Stakeholder Engagement: Regularly engage with stakeholders to ensure alignment on project deliverables.

Problem Solving: Apply systems thinking to manage unforeseen circumstances effectively.

Analytical Thinking: Review, analyze, interpret, and summarize system and process data.

Essential Qualifications

• General Experience: Over 3 years in a pharmaceutical or GMP environment, with expertise in one or more of the following:

1. Quality Systems and Operation

2. Quality Control

3. Manufacturing

4. Engineering

5. Technology Transfer

Fresh graduates and those with lesser experience may be considered for Junior roles.

• Commissioning, qualification and validation (CQV) Experience: Knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, IQ/OQ/PQ Protocols, etc) in CQV disciplines such as CIP, SIP, process, utility, process equipment, automation, computer system, lab system.
  • Education: Minimally a Bachelor's degree in Engineering or Science, or a related technical discipline, or equivalent relevant experience.
    • Regulatory Knowledge: Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4, and other regulatory requirements.
    Valuable Experience
    

Deviation Handling: Experience with root cause analysis and CAPA management.

Advanved Technical Knowledge: Possess advanced technical knowledge in more than 1 CQV discipline.

Quality Control: Experience with aseptic techniques, LIMS qualification, MES troubleshooting, and test methods validation (sterility tests, disinfectant tests, etc.).

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.

Tell employers what skills you have

Document Management
Pharmaceutical Industry
Quality Control
Risk Assessment
Regulatory Compliance
Quality Assurance
Technology Transfer
GMP
Investigation
Protocol
Biotechnology
Computer System Validation
Equipment Qualification
LIMS
Regulatory Requirements
Life Sciences
Acceptance Testing
Laboratory
Commissioning
Analytical Instruments

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