Job Description

To design the Mechanical and Electrical systems of Bio/Pharmaceutical Manufacturing facility and support the business development efforts in conceptual design, basic, and detail engineering, proposal preparation and assist in technical presentation to customers as well as responsible for engineering execution and project management including plant commissioning and validation. To function as a member of a team as well as in individual assignments. To be prepared for both short and long term outstation/overseas project assignments.

Key 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 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.

Job Requirements

• Experience: At least 1-3 years of professional background in Monitoring & Evaluation or Pharmaceutical engineering in the Malaysian construction or consultancy industry.
• Languages: Proficiency in English and Bahasa Malaysia is essential; knowledge of Mandarin is a bonus for contractor and overseas communication.

Skills