NSQF-Bio Process Engineer.pdf

Bio Process Engineer

  • Job DescriptionThe Engineer is responsible for providing technical and scientific support for ongoing manufacturing operations of biopharmaceutical products. The role holder also helps in design and development of artificial organs, prostheses and innovative technologies.
  • CodeLFS/ Q 0219
  • SectorLife Sciences
  • NSQF LevelLevel 5
  • Notional Hours425
  • Accrediting BodiesLife Sciences Sector Skills Council
  • Certifying BodiesLife Sciences Sector Skills Council
  • Proposed Occupation

    Bio Process Engineer falls under Manufacturing Occupation. The Job role holder is responsible for providing technical support in the operational implementation and performance aspects of biochemical drug substance manufacturing plants. The role holder supports design. development. and evaluation of biological and health systems and products. such as artificial organs. prostheses. instrumentation. medical information systems. and health management and care delivery systems. The individual is required to apply knowledge of design or commissioning of a mammalian cell-based biopharmaceutical manufacturing plant. functional knowledge of production equipment and knowledge of bioprocess technology transfer and/or scale-up technology manufacturing and upstream mammalian cell culture. The individual uses skills like analytical thinking. critical thinking. planning and organizing. communication skills. problem solving and decision making skills. Bio process engineer has responsibility of own work and learning and some responsibility for other's work and learning.

  • International Comparability

    While preparing the NOSs, a detailed secondary desk research was conducted. The European, South African and Australian NOSs were referred to. The relevant International NOSs for the job role are listed below for reference: UK NOS • COGLS204 Maintaining equipment in life sciences and related industries • COGLS308 Diagnose faults,repair and maintain equipment in life sciences and   related industries • SFHPHARM23 check documentation and materials • COGLS202 Maintain effective and efficient working relationships in life Sciences and related industries • COGPIO3.2 control emergencies  • COGLS201 Follow health and safety procedures in life sciences • COGLS301 Maintain health and safety in life sciences Switzerland NOS Refer page no.109, Unit Group 1321 Australia NOS • Operate a water purification process • Contribute to the application of a proactive maintenance strategy • Conduct routine maintenance • Participate effectively in a workplace environment • Participate in OHS processes South Africa NOS • Act in accordance with ethical and legal codes of pharmaceutical representation and the laws of the country • Apply ethical and legally compliant behaviour in pharmaceutical and health environments.

  • Progression Pathway

    Upward progression: Production Plant Manager (Level 6) Lateral/ Horizontal progression: Production Planning Engineer (Level 5) Research Associate- Product Development/ Technical (Level 5)

  • Qualification File NSQF-Bio Process Engineer.pdf
  • Supporting Documents
  • Formal structure of the qualification
    Title of unit or other component Mandatory/ Optional Estimated size (Hours) Level
    LFS/N0247: To provide operational support for daily manufacturing activities Mandatory 50 Level 5
    LFS/N0248: To support R&D capabilities Mandatory 80 Level 5
    LFS/N0249: To assist in development and execution technical transfer plans process transfer and validation protocols Mandatory 100 Level 5
    LFS/N0250: To carry out reporting and documentation for bioprocessing activities Mandatory 75 Level 5
    LFS/N0103: To ensure cleanliness in the work area Mandatory 30 Common across Level 2-6
    LFS/N0251: To coordinate with manager and team members to carry out bioprocessing activities Mandatory 45 Level 5
    LFS/N0101: Maintain a healthy safe and secure working environment in the life sciences facility Mandatory 45 Common across Level 2-7