CQV / MSAT Engineer / Consultant (Pharmaceutical Process)

Key Responsibilities:

• Deliver consulting projects in the process-related areas including but not limited to Technology Transfer, Cleaning Validation (CV), Sterilization-in-Place (SIP) PQ, Process Qualification, Shipping Validation and Process Validation.
• Draft CQV deliverables such as URS, risk assessment, data integrity related assessment and CV / SIP PQ / PQ / Shipping Validation / PV protocols.
• Execute CQV protocols and draft reports.
• Draft validation strategy for CV, SIP PQ, process qualification and process validation.
• Draft protocols for process comparability, resin lifecycle management, stability study and other process related protocols.
• Draft Technology Transfer documentations such as facility fit assessment, control strategy, etc.
• Support business and service development initiated by the management of Orka.

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.
• Fresh graduates with internship in pharmaceutical or medical device industry and some relevant experience may apply for a Junior role.
• Have working experience in MSAT or pharmaceutical process related roles.
• Have working knowledge of DeltaV including for logics such as handshakes and prompts
• 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.

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.