Automation / System Engineer (Pharma)

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 possessing Intelligence, Resourcefulness, Loyalty and Teamwork characteristics.
• 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.