PSC BIOTECH PTE. LTD.
PSC BIOTECH PTE. LTD.

PSC Biotech Pte. Ltd. is the industry recognised leader in Validation and other Quality and Compliance services. Our full time consulting staff provides a broad range of outsourced services to the biotech, pharmaceutical, medical device and diagnostic industries.

PSC Biotech Pte. Ltd. is also one of the leading BioPharma consulting firms in the United States. Combining experience and our technology, PSC creates innovative workforce initiatives and long-term solutions to the pharmaceutical industry.

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Process Engineer (Biopharma) - 1 year

  Company :     Working Hours :  

  Job Type :  

Part Time

  Salary :  

$4,500 - $5,200 / monthly



Job Description

Responsibilities:

  • Involve in developing technical operations documents, including the establishment of validation plan, project protocols and associated study plans and reports
  • Ensure all activities are consistent with Safety, GMP, GAMP and other regulatory requirements
  • Manage contractors / vendors and ensure design deliverables are being executed, submitted and approved on time
  • Coordinate and ensure project design documents (P&IDs, PFDs, data sheets etc.) are maintained and updated correctly as per specification
  • Lead the design reviews, HAZOPs and other types of safety & design reviews
  • Lead the project change control related to P&IDs, PFDs, URS and closeout
  • Contribute and input to Process elements within Revenue and Capital budgets and Key Performance Indicators
  • Identify, evaluate and inform the line management on risks affecting the project
  • Support User Requirements Specification development for the packages
  • Support FAT execution, start-up/commissioning and qualification activities together with external contractors and the USER in accordance to valid SOPs
  • Support the commissioning field team with specific process tasks
  • Support the management of change and ensured that the change is controlled, communicated and implemented in the most cost effective and timely manner
  • Assist in schedule development and identified schedule conflicts and resource limitations
  • Manage and close out deficiencies during static and dynamic commissioning
  • Conduct kickoff and weekly meeting with the contractors/vendor for the packages
  • Support the site acceptance tests activities of the packages
  • Adhere to any applicable EHS requirements
  • Manage contractors in accordance with Company procedures

Requirements

  • Diploma or Degree in Sciences or Engineering
  • At least 3 years of experience in cGMP biopharmaceuticals manufacturing process operations
  • Experience in writing of technical documents, including validation documents, protocols and reports
  • Strong knowledge of Good Manufacturing Practice (cGMP) is a must

 Location: 26 BOON LAY WAY TRADEHUB 21 609970.  How to get there?

 Location: 26 BOON LAY WAY TRADEHUB 21 609970.




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