Automation / System Engineer (Pharma)

ORKA LIFESCIENCE PARTNERS PTE. LTD.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

SDLC knowledge

Quality management understanding

Pharma/medical device domain

Regulatory compliance awareness

Education

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

Tools

DeltaV

OSI PI

21 CFR Part 11

Job description

Key Responsibilities:

• 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.

Requirements:

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.


• Have worked for at least 4 years in pharmaceutical, medical device or related environment.


• Have experience in designing and commissioning of process automation or historian systems for pharmaceutical industries (batch operations).


• Have worked with automation hardware and OT shop floor technologies.


• Understand pharmaceutical manufacturing operations.


• Understand computerised system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11) and industry best practice documents / standards (e.g., GAMP5, ISA 88, ISA 95).


• Understand SDLC and quality management requirements of the pharmaceutical industry.


• Preferably with relevant training and certifications.

Why Join ORKA:

• Work that Matters:Support clients bringing innovative and life saving solutions to the population.


• Career Development:Build a consulting career in a professional consulting company with Life Sciences focus.


• Professional Environment:Work with similar professionals possessingIntelligence, Resourcefulness, Loyalty and Teamworkcharacteristics.


• Impactful Learning and Mentoring:Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.