- 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.
- 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).
- 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