Short Job Description:

The CQV Consultant / Engineer delivers commissioning and qualification services for equipment such as temperature controlled equipment / temperature controlled unit, warehouse and process equipment. The Consultant / Engineer ensures that all systems are installed, tested, and qualified in compliance with cGMP, regulatory requirements, and project-specific standards.

Key Responsibilities:

• Deliver consulting projects to support introduction and upgrade of manufacturing, manufacturing support and laboratory equipment in the Life Sciences clients.
• Draft equipment qualification deliverables such as URS, risk assessment, data integrity related assessment, CQ (IQ/OQ) protocols, specifications and RTM.
• Execute equipment qualification activities.
• Monitor and support equipment vendor in conducting equipment CQ, calibration and maintenance.
• Perform document control activities including change management.
• Draft, revise and review SOPs, forms and related operational and maintenance documents.

Requirements:

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.
• Have worked for at least 2 years in pharmaceutical, medical device or related environment.
• Fresh graduates with internship in pharmaceutical or medical device industry and some relevant experience may apply for a Junior role.
• Have working experience in manufacturing or laboratory operations and equipment.
• Understand computerised system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11).
• Preferably with experience performing mapping of temperature controlled system such as incubator, fridge, freezer, autoclave or warehouse.
• Preferably familiar with process tank, FIT machine, ViCell, spectrophotometer, pH / conductivity meter, osmometer, etc.
• Preferably with experience in using VLMS like Kneat.

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 Intelligent, Resourceful, Loyal 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.