Job Description

Short :

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.