Senior/Consultant (PI Historian) Pharma/Biotech

1 day ago

Singapore NNIT SINGAPORE PTE. LTD. Full time
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 PI Historian, you will be supporting our clients on PI System/Server-related projects.
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
  • Technical Proficiencies:
  • PI system (AVEVA PI or IP.21 Historian) knowledge.
  • Computer system setup, including virtualization, hardware and software.
  • Interface experience (E.g AVEVA PI System Asset Framework (AF), Historian, PI Vision (Visualization), SQL and PI (OPC, EMDVB, MES)).
  • Integration experience (PCS7/DeltaV and/or MES).
  • Maintenance of Plant Information Management System (PIMS).
  • Installation, administration, and troubleshooting computer data networks and servers
  • Troubleshooting: Experience with System Monitoring/Resolution, System Maintenance, System Break/Fix & Outage Notification/ Management.
  • 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.
Essential Qualifications
  • Experience: Over 3 years in a pharmaceutical or GMP environment, with experience supporting AVEVA PI (previously known as OSI PI).
Fresh graduates, preferably with internship in pharmaceutical industry, and those with lesser experience may be considered for Junior roles. Those with experience in PI Project Management will be considered for Lead roles.
  • Education: at least Bachelor's degree in Engineering or Life Sciences- related field of study.
  • Regulatory Knowledge: Good understanding of 21 CFR Part 11 - Electronic Records/Electronic Signatures (ERES), GAMP 5 Computerized Systems Validation (CSV), ANSI/ISA-S88 and S95 industry standards
Valuable Experience
  • Incident Management: Conduct root cause analysis and contribute to post-incident reviews, ensuring corrective actions and improvements in security measures.
  • Cybersecurity: Experience in enterprise cyber resilience and implementing cyber security controls.
  • Change Management: Experience in managing the change control process, including documenting, assessing, and implementing changes to 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.

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