CQV / MSAT Engineer / Consultant (Pharmaceutical Process)

Key Responsibilities:

• Support process-related projects including but not limited to Technology Transfer, Cleaning Validation (CV), Sterilization-in-Place (SIP) PQ, Process Qualification and Process Validation (PV) / Process Performance Qualification (PPQ).
• Draft Technology Transfer documentations such as facility fit assessment, control strategy, etc.
• Draft and review CQV and/or technology transfer deliverables including but not limited to risk assessment, technical justification / strategy / approach and qualification / validation protocols.
• Support CQV / PQ / PPQ activities.
• Support process comparability, resin lifecycle management, stability study and other process related activities.

Requirements:

• Hold Bachelor’s degree in Life Sciences, Engineering or related field.
• Have worked for at least 5 years in pharmaceutical, medical device or related environment.
• Have either pharmaceutical manufacturing or MSAT experience.
• Have working competency in the area of Fermentation, Centrifugation, chromatography and/or TFF/UFDF processes.
• Have very good understanding of the science behind manufacturing operations.
• Have good understanding of regulatory requirements and relevant industry best practice.
• Preferably have 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. Grown in breadth and depth of both technical knowledge and compliance understanding.
• 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.