Process Engineer (Pharmaceutical)

Denpasar, Bali, Indonesia
29 days ago

Description

This role will be based in our office in Bali, Indonesia. Only candidates who are allowed to work in Indonesia need to apply.
  • The candidates have to be proficient in English as the role requires supporting projects outside of Indonesia.
  • The ideal candidates should have experience or a strong interest to pick up skills in the following areas:
  • Develop engineering drawings (eg. P&IDs, PFDs, GAs, line diagrams, etc.) and 3-D piping and equipment design using AutoCAD, Bentley, Inventor, Solidworks, etc., and current sanitary design requirements as per ASME BPE. The expectation is that the process engineer should be able to draft or model on his/her own or pick up these skills along the way.
  • Write, review and defend technical documents such as CQV test protocols (IQ/OQ/PQ), SOPs, deviation reports, tech memos, etc;
  • Critique and evaluate engineering documents such as technical specs, equipment/component/instrument data sheets, P&IDs, piping isometrics, GA drawings, sizing calculations, functional specifications, etc;
  • Demonstrate ability to lead technical projects from concept through implementation.
  • Perform activities like FAT/SAT and Installation verification for new equipment and also for modifications to existing equipment.
  • Perform Software FAT.
  • Review vendor turnover package documentation.
  • Manage equipment construction activities associated with the implementation of engineering projects.
  • Support all phases of engineering project implementation to meet scope, schedule, budget, quality, and safety requirements.
  • Coordinate with a multi-disciplinary team like Automation, Manufacturing, Technical Services, and Validation for improvements or implementing changes associated with engineering projects.
  • Draft and execute commissioning protocols related to production equipment in the Cell Culture or Purification areas.
  • Responsibility to adhere to any applicable EHS requirements.
  • Commitment to a fair and respectful relationship with others and behavior in accordance with the Company's Code of Conduct.
  • Any other duties as assigned by the process engineering team.
  • Job Skills & Qualifications

Requirements

Required:
  • A good understanding of design principles and standards within biopharmaceutical facilities.
  • Process and equipment knowledge of biological drug substance manufacturing processes; upstream/downstream unit operations expertise is highly preferable.
  • Read &Understand Software Functional Specifications.
  • Knowledge/ Experience in DeltaV and/or PLC programming is an added advantage.
  • Thorough knowledge of current Good Manufacturing Practices (cGMP) and Good Engineering Practices (GEP).
  • Good knowledge of EHS and risk management practices.
  • Good Project Management Skills
  • Understanding equipment commissioning, various stages of qualification, and process activities
  • Good communication skills.
  • Ability to work both independently and as part of a team.
  • Punctual and able to meet deadlines.
  • Excellent oral and written communication skills.
  • Being hands-on.
  • Open to travel and work at project sites outside Indonesia
  • Ability to multi-task
  • Adaptable and curious
Preferred:
  • Experience with 3D Modelling programs such as AutoCAD
  • Minimum diploma in Mechanical Engineering / Electrical Engineering / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Biotechnology / Chemical & Biomolecular
  • Experience in bio-processing engineering in a manufacturing environment is highly desirable
  • Experience in a GMP environment is preferred.

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