CSV Engineer Delta V (Pharma/Biotech)

The position will require knowledge of the DeltaV programming for the purposes of generating CSV Lifecycle documents for DeltaV processes – VP, Protocols (generation and post-execution review, and Summary Reports).

Responsibilities:
Manage Computer System Validation Lifecycle from design to execution phases; Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols.

Responsible for preparation of CSV documents and protocols, perform execution for automated equipment and/or control systems, and closure of executed protocols.

Perform troubleshooting during test execution.

Responsible for execution of thermal mapping activities.

Write execution related deviations and change requests.

Any other task as assigned by Supervisor/Manager.

About You:
Diploma/Bachelor Degree in Computer Science/IT, Engineering or Industrial Instrumentation and Process controls.

Min. 3 years of experience in CSV preferably in a biotech facility.

Good knowledge of validation lifecycle, compliance requirements (GAMP 5, 21 CFR Part 11 and regulatory requirements), and current Good Manufacturing Practices (cGMP)

Familiar with Health Authorities standards (e.g., FDA CFR and EU)

Knowledge of thermal mapping validation and usage of data logger is a plus.

Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams

Must be team player, curious with strong analytical and organizational skills

Contract Duration: 6 months

Nusantara Prime Consulting Pte. Ltd (NPC)

is a Singapore based private limited company that focuses on technical consulting solutions led by a team of industry practitioners.

Our Specialist Services include Pharmaceutical focus on Process/Project Engineering and Design, Project Management, Technology Transfer, Regulatory affairs, Commissioning, Qualification, Validation, Quality Assurance & Control and Waste Water processing consultation with aim of ZLD (Zero Liquid Discharge) for a circular economy to clients in the Biopharmaceuticals, Life Sciences and Food and Beverage (F&B) industry in the ASEAN region.

Our Mission

With a holistic thought process, we are dedicated to partnering with our clients on end-to-end solution support delivering life-saving therapeutic drugs to the patients.

Our Vision

To be the most successful and ground-breaking consulting agency; providing best-in-class products and services to support our customers in producing quality healthcare timely and economically.