CQV / MSAT Engineer / Consultant (Pharmaceutical Process)

5 days ago

Singapore ORKA CONSULTING PARTNERS PTE. LTD. Full time $90,000 - $120,000 per year
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.

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