Senior/Consultant (Digital Manufacturing/MES/Computer System Validation) [Pharma/Biotech]
1 week ago
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:
- GxP Computer Systems Validation in laboratory equipment or manufacturing equipment
- Manufacturing Execution System (MES) (e.g., Emerson Syncade, Körber/ Werum PAS-X, Siemens Opcenter Execution Pharma, POMSnet, Rockwell PharmaSuite)
- 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.
-
Singapore NNIT SINGAPORE PTE. LTD. Full timeAbout 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...
-
Singapore NNIT SINGAPORE PTE. LTD. Full timeRoles & ResponsibilitiesAbout UsHeadquartered 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...
-
Singapore beBeeCareer Full timeLife Sciences Consultant Job Overview NNIT is seeking experienced professionals from the life sciences industry for a full-time on-site role at client locations in Singapore. As a Senior/Consultant in Digital Manufacturing, Computer System Validation (CSV), you will be supporting clients through the entire project lifecycle in ensuring all computer systems...
-
MES Analyst
4 days ago
Singapore Manpower Singapore Full timeMES Analyst - Digital Transformation & Automation (Pharma) This range is provided by Manpower Singapore. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range MES Support Analyst (Digital Transformation/ Automation/ Pharma) 12-Months Contract Location: Tuas Salary up to $7,000...
-
MES Support Analyst
1 week ago
Singapore Manpower Singapore Full timeOverview MES Support Analyst (Digital Transformation/ Automation/ Pharma) – 12-Months Contract – Location: Tuas – Salary up to $7,000 depending on experience – Industry: Pharmaceutical Responsibilities Configure system components including workstation assignments, printers, weighing scales, and access rights. Maintain and update specification...
-
Computer System Validation Engineer
1 week ago
Singapore PHARMENG TECHNOLOGY PTE. LTD. Full timePharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective...
-
MES Support Analyst
1 week ago
Singapore Manpower Singapore Full timeOverview MES Support Analyst (Digital Transformation/ Automation/ Pharma) – 12-Months Contract – Location: Tuas – Salary up to $7,000 depending on experience – Industry: Pharmaceutical Responsibilities Configure system components including workstation assignments, printers, weighing scales, and access rights. Maintain and update specification...
-
Engineer, Manufacturing System
1 week ago
Singapore CIBA VISION ASIAN MANUFACTURING AND LOGISTICS PTE. LTD. Full timeTo drive automation, software and system related enhancements or key projects including site / manufacturing expansion projects. - To ensure systems are in compliance to site Quality and HSE requirements **Responsibilities** - Maintain, support and administrate the MES system. Perform MES system change and related enhancements / bug fixes. - Maintain and...
-
Digital Manufacturing Specialist
2 weeks ago
Singapore beBeeManufacturing Full time $80,000 - $140,000About Our Job OpportunityWe are seeking experienced professionals with expertise in digital manufacturing, computer system validation, and software applications. As a Senior/Consultant, you will support our clients through the entire project lifecycle, ensuring all computer systems and software applications are validated according to industry standards,...
-
Validation Engineer
1 week ago
Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full timeSupport equipment, facilities, utilities qualifications Develop validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and complete execution in a timely fashion Manage qualification execution and lead qualification deviation investigations encountered during...
