Cqv Engineer

**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 / IOQ 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.
- 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.

Pay: From $4,200.00 per month

Work Location: In person