Pharma Process Automation & Validation Engineer

ORKA LIFESCIENCE PARTNERS PTE. LTD.; Singapore; Vor Ort; SGD 90.000 - 130.000; Vollzeit

Zusammenfassung

ORKA LIFESCIENCE PARTNERS PTE. LTD. in Singapore is seeking an experienced automation professional to design, develop and commission DCS and data historian systems for pharmaceutical operations, including DeltaV and OSI PI.

You will draft commissioning and qualification documents (FAT, UAT, IQ, OQ), support system architecture, change control, CSV, and system administration, working with regulated environments and GMP standards.

Qualifikationen

• Bachelor's degree in Life Sciences, Engineering or related field.
• At least 4 years in pharmaceutical, medical device or related environment.
• Experience in designing and commissioning process automation or historian systems (batch operations).
• Familiarity with regulation and industry standards (21 CFR Part 11, Annex 11, GAMP5, ISA 88/95).
• Understanding SDLC and quality management requirements.

Aufgaben

• Design, develop, configure and commission Distributed Control System (DCS) (e.g., DeltaV) or data historian (e.g., OSI PI).
• Draft and execute commissioning and qualification documentations such as FAT, UAT, IQ and OQ.
• Support system architecture design, specification development, control strategies and library development.
• Contribute to change management, deviation / non-conformance and system documentations.
• Support Computer System Validation (CSV) activities.
• Support System Administration.

Kenntnisse

SDLC knowledge

Quality management understanding

Pharma/medical device domain

Regulatory compliance awareness

Ausbildung

Bachelor's degree in Life Sciences, Engineering or related field

Tools

DeltaV

OSI PI

21 CFR Part 11

Jobbeschreibung

ORKA LIFESCIENCE PARTNERS PTE. LTD. in Singapore is seeking an experienced automation professional to design, develop and commission DCS and data historian systems for pharmaceutical operations, including DeltaV and OSI PI.

You will draft commissioning and qualification documents (FAT, UAT, IQ, OQ), support system architecture, change control, CSV, and system administration, working with regulated environments and GMP standards.