Short Job Description:

The CQ Engineer delivers commissioning and qualification services for equipment such as temperature controlled equipment / temperature controlled unit, warehouse, laboratory equipment (e.g., TOC analyzer, micro plate reader, MALDI-TOF, HPLC, osmometer), manufacturing support equipment (e.g., weighing balance, pH meter, weighing balance, CEDEX, ViCell, Solo VPE), HVAC, utilities (e.g., WFI, compressed air) and process equipment. The Engineer ensures that all systems are installed, tested, and qualified in compliance with cGMP, regulatory requirements, and project-specific standards.

Key Responsibilities:

• Deliver CQ services to support introduction, upgrade or decommissioning of manufacturing, manufacturing support and laboratory equipment in the Life Sciences (pharmaceutical / medical device) clients.
• Draft equipment qualification deliverables such as URS, risk assessment, data integrity related assessment, CQ (IQ/OQ) protocols, specifications and RTM.
• Review equipment vendor's IOQ documents.
• Execute and document qualification activities.
• Monitor and support equipment vendor in conducting equipment CQ, calibration and maintenance.
• 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 experience supporting or performing equipment CQ activities.
• Understand computerised system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11).
• Preferably with experience in using VLMS like Kneat or Valgenesis.

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.