Senior/Junior Process or Validation Engineer

About the role

Design bio/pharmaceutical manufacturing processes and facilities (concept, basic and detailed design) in close cooperation with other disciplines.

Key responsibilities

• Compile related design documents including process flow diagrams, user requirement specifications (URS), tender specifications (TS), and P&IDs

• Manage engineering execution and project management during plant construction, commissioning, and qualification

• Conduct technical and commercial review of quotations and bids

• Attend meetings with users, customers, and external parties

• Commission and qualify process and equipment according to cGMP and other relevant regulations

• Liaise with local authorities during application and approval processes

• Coordinate with other disciplines, partners, sub-consultants, and sub-contractors

• Support business development efforts in feasibility study phase and proposal stage

• Assist in technical presentations to clients

  Requirements:

  • Candidate must possess at least a Bachelor's Degree in Pharmaceutical Engineering, Chemical/Mechanical/Electrical Engineering, Bio-Technology, Science or equivalent.
  • At least 3 years of working experience with minimum of 2 years in the pharmaceutical or bio-tech industries with proven experience in pharmaceutical/bio-tech manufacturing process and facility design.
  • Good understanding of cGMP compliance and associated legislative standards, i.e. PIC/s, EU GMP and US FDA standard for the pharmaceutical industry.
  • Experience in preparation and execution of commissioning and qualification protocols.
  • Familiar with AutoCAD, MS Project, MS Office applications.
  • Based in Malaysia but willing to travel (local and overseas).

  Other Requirements：

  • Accountable for results with proactive attitude
  • Creative, self-motivated, actively participate in specific initiatives and promote positive company culture
  • Open-minded and ready for change
  • Cooperate and collaborate with business partners with good teamwork spirit
  • Customer focus, understand and satisfy internal and external customers
  • Continuously improvement
  • Excellent communication, negotiation and interpersonal skills in English and other languages
  • Detail-oriented with good planning and organizing skill
  • Provide high quality solution for customer and work in an efficient and timely manner
  • Have a good knowledge in QA/QC including testing in chemical and biological.