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Jobs in Malaysia   »   Jobs in Subang Jaya   »   Engineering jobs   »   Process/Validation Engineer

Process/Validation Engineer

Subang Jaya, Selangor, MY
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Responsibilities: 

- To design bio/pharmaceutical manufacturing process and facility (concept, basic and detailed design) in close cooperation with other disciplines. 
- Responsible to compile related design documents e.g. process flow diagrams, user requirement specifications (URS), tender specifications (TS), P&IDs, etc.
- Responsible for engineering execution and project management during plant construction, commissioning, and qualification. 
- Technical and commercial review of quotations/bids.
- Attend meetings with users/customers/external parties.
- Commission and qualify process and equipment according to cGMP and other relevant regulations.
- Liaise with local authorities during application and approval process.
- Coordination with other disciplines, partners, sub-consultants, sub-contractors, etc.
- To support the business development efforts in feasibility study phase, proposal stage and assist in technical presentation 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 5 years of working experience with minimum of 3 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

Perks & Benefits

  • Flexible working hours
  • Casual dress code
  • Personal development opportunities

Job Location
C-05-01&02, Sky Park One City, Jalan USJ25/1, 47650 Subang Jaya, Selangor, Malaysia
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Company Overview

Nova Pharma Solutions Berhad, a leading engineering and consulting company within the life science industry. We work with some of the world’s most prominent pharma and biotech companies and help them develop, establish and improve their manufacturing and ensure regulatory compliance. Designing for Healthier Future – our role in an industry that improves people’s lives worldwide. Why join us? Quite simply, we see people as people, not as a workforce. We treat and respect every colleague with the knowledge that we share a common vision of a healthier world. If you are the best at what you do, we suggest that you consider a career with us.

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Company Summary
Nova Pharma Solutions Berhad
http://novapharmasolutions.com/
Healthcare / Medical

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