CQV / MSAT Engineer / Consultant (Pharmaceutical Process)

2 weeks 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 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...

  • Cqv Engineer

    6 days 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...

  • CQV Engineer

    23 hours ago

    Singapore MORIMATSU PHARMADULE (SINGAPORE) PTE. LTD. Full time $90,000 - $120,000 per year

    About the RoleJoin 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 production.Job...

  • Senior CQV Process Engineer

    11 hours ago

    Singapore INTEGRIX SOLUTIONS PTE. LTD. Full time

    About the Role: We invite highly motivated individuals to join our team in providing support to our clients' biomanufacturing facilities. In this role, you will be tasked with performing pre-commissioning checks and detailed testing, troubleshooting process/equipment issues, preparing comprehensive reports, collaborating with cross-functional teams, and...

  • Cqv Engineer

    2 days ago

    Singapore PM Group Full time

    : PM Group is currently looking to expand the CQV capabilities in Singapore. We are looking for CQV Engineers who will bring their expertise with them and drive our projects to completion. : - Field execution of Commissioning, Installation & Operational Qualification (IQ/OQ), Verification for downstream process equipment, CIP, & Clean utilities -...

  • CQV Engineer

    5 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 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...

  • CQV Engineer

    2 weeks ago

    Singapore ANTER CONSULTING PTE. LTD. Full time $80,000 - $120,000 per year

    About the RoleWe 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...

  • Lead Cqv Engineer- Process/fue-pharma

    6 days 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 the US, our core focus is on consistently delivering high-quality outcomes for our multinational...

  • CQV Consultant

    2 weeks ago

    Singapore ORKA CONSULTING PARTNERS PTE. LTD. Full time $60,000 - $120,000 per year

    Short Job Description:The CQV Consultant / Engineer delivers commissioning and qualification services for equipment such as temperature controlled equipment / temperature controlled unit, warehouse and process equipment. The Consultant / Engineer ensures that all systems are installed, tested, and qualified in compliance with cGMP, regulatory requirements,...

  • CQV Engineer

    2 weeks ago

    Singapore LANYOU TECH PTE. LTD. Full time $90,000 - $120,000 per year

    Job DescriptionThe CQV Engineer is responsible for the commissioning, qualification, and validation of CU/Cleanroom/Temperature Controlled Unit/Process systems. The role ensures that all systems are installed, tested, and qualified in compliance with cGMP, regulatory requirements, and project-specific standards.RequirementsBachelors Degree in Engineering,...