CQV / MSAT Engineer / Consultant (Pharmaceutical Process)

7 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.

  • Biopharma MSAT Engineer

    11 hours ago

    Singapore Process Engineering Specialists (PES) Full time

    PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high-quality outcomes for our multinational clients....

  • Cqv Engineer

    1 week ago

    Singapore MORIMATSU PHARMADULE (SINGAPORE) PTE. LTD. Full time

    **About the Role**: Join our team as a **CQV (Commissioning, Qualification & Validation) Engineer**, supporting the start-up and validation of state-of-the-art pharmaceutical/biotech manufacturing facilities. You will work closely with project, engineering, and quality teams to ensure all systems meet GMP compliance and are ready for commercial...

  • Biopharma MSAT Engineer

    10 hours ago

    Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high-quality outcomes for our multinational clients....

  • Msat Process Development Senior Scientist

    2 weeks ago

    Singapore No Deviation Pte Ltd Full time

    About No deviation At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful...

  • Msat Process Development Technician

    2 weeks ago

    Singapore No Deviation Pte Ltd Full time

    About No deviation At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful...

  • Msat Process Development Technician

    2 weeks ago

    Singapore No deviation Pte Ltd Full time

    About No deviation At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful...

  • CQV Engineer

    1 week ago

    Singapore GOOD JOB CREATIONS (SINGAPORE) PTE. LTD. Full time

    Responsibilities: Plan, execute, and manage commissioning, qualification, and validation (CQV) activities for pharmaceutical/biotech manufacturing facilities, utilities, and process equipment. Develop and review CQV protocols (IQ/OQ/PQ) and reports in compliance with GMP, GAMP 5, and company procedures. Coordinate with engineering, project, and quality teams...

  • CQV Engineer

    2 days ago

    Singapore GOOD JOB CREATIONS (SINGAPORE) PTE. LTD. Full time

    Responsibilities: Plan, execute, and manage commissioning, qualification, and validation (CQV) activities for pharmaceutical/biotech manufacturing facilities, utilities, and process equipment. Develop and review CQV protocols (IQ/OQ/PQ) and reports in compliance with GMP, GAMP 5, and company procedures. Coordinate with engineering, project, and quality teams...

  • CQV Engineer

    2 weeks ago

    Singapore NO DEVIATION PTE. LTD. Full time $90,000 - $120,000 per year

    About No deviationAt No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful...

  • Cqv Engineer

    7 days ago

    Singapore ANTER CONSULTING PTE. LTD. Full time

    **About the Role**: We are hiring an experienced CQV Engineer (Clean Utilities & HVAC) to join our our team supporting our client on the execution phase of a brownfield pharmaceutical expansion in Singapore. This role will focus on hands-on execution, coordination, and closure of qualification activities to ensure readiness for operational use and regulatory...