PHARMACEUTICAL
Job Description
An experienced Process engineer/Senior Process engineer to be responsible for the process design, operation and implementation and to lead technical project execution activities on all design phases as well as installation, start up, implementation.
Duties & Responsibilities
- To prepare proposal writeup, manhour estimate and schedule planning for tender bidding.
- To carry out Basic process engineering design package, work in feasibility studies, Front End Engineering Design (FEED) and detail engineering design.
- To generate project specifications, Process description, PFDs, P&IDs, Mass and Energy balances calculations, as well as review vendor documents.
- To coordinate with Project Team and other Department Engineers to facilitate smooth progress of engineering work.
- To lead and execute exciting projects and will provide support and offer guidance for internal activities such as: mock projects, toolbox development and mentoring of less experienced teammates.
- To conduct and Lead HAZOP, HACCP, PHA studies.
- To create and carry out qualification protocols like IQ/OQ/ PQ, URS, FATs, SATs.
- To support the Commissioning Team during plant or unit commissioning and start-up.
Requirements
- Bachelor’s degree in Chemical or Pharmaceutical engineering.
- 10 -15 years and above of relevant process experience, skills, knowledges and abilities expected.
Skill Requirements
· Knowledge of international or local standard/code (e.g. GMP, ISPE baseline Guide, ASME BPE, and so forth).
· Experience working in FDA, CGMP, GMP, CGDP.
· Extensive experience with Planning and support process (DSP, USP…etc.) preferably within the pharmaceutical industry
· Knowledge in process design, Clean and Grey utilities, CIP/SIP technologies, solvent recovery, containment, and regulatory requirements.