MSAT / CQ Engineer (Cleaning / SIP Validation)

Key Responsibilities:

• Author, review, and approve Cleaning Validation or SIPPQ 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) or SIP PQ 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.
• 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. ORKA has several very experienced personnel in Cleaning Validation (CV) and other CQV disciplines.