CQV / MSAT Engineer / Consultant (Cleaning Validation)

Responsibilities

• Author, review, and approve Cleaning Risk strategy documents including assessments, protocols, and reports.
• Brief and guide cross functional teams on validation strategy and execution.
• Develop cleaning cycle development protocols, support execution, and optimize cleaning processes.
• Coordinate validation execution, sampling, and data review.
• Troubleshoot cleaning issues and support investigations and CAPA.
• Deliver other consulting projects in the process-related areas including but not limited to Technology Transfer, Sterilization-in-Place (SIP) PQ, Process Qualification and Process Validation.
• Draft other deliverables within full CQV cycle such as URS, risk assessment and data integrity assessment.

Requirements

• Hold Bachelor's degree in Life Sciences, Engineering or related field.
• Have worked for at least 3 years in pharmaceutical, medical device or related environment.
• Have at least supported Cleaning Validation (CV) activities as manufacturing or MSAT personnel.
• Preferably understand cleaning validation requirements and assessments including the concept of Health-Based Exposure Limit (HBEL), MACO, etc.
• Have working competency in the area of Fermentation, Centrifugation, chromatography and/or TFF/UFDF processes.
• Have good understanding of regulatory requirements and relevant industry best practice in Cleaning Validation (CV).
• Preferably with working knowledge of DeltaV including for logics such as handshakes and prompts
• 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.

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