Operation Support Specialist (RJ)

at  No Deviation Pte Ltd

Scope and Responsibilities:

• Supports the plan, schedule and coordination of maintenance activities with maintenance team and IPT planner with support from other engineers and Senior Manager. Supports activities that interfere with production in order to reduce downtime.
• Supports all permits in the operations areas. Supports to ensure that all work is successfully completed.
• Serve as landlord for facility with support from other engineers and Senior Manager. Works with operations staff and maintenance team to correct deficiencies in housekeeping, maintenance, and facility- related procedures.
• Manage materials and supplies storage and logistics within facility.
• Ability to generate and support qualification and functional verification document for commissioning.
• Participates/supports equipment commissioning, including FAT / SAT.
• Generates/supports plant modification proposals and track changes to completion.
• Generates/supports generation of cleaning batch sheets for product change-over and new equipment.
• Participate in cleaning development and cleaning validation activities
• Will support PTO in technology transfers for new product introductions into the plant.
• Manage the operations supply system, including coordination with planner/buyer and maintenance team, to ensure that material and supply inventories are maintained at appropriate inventory levels.
• Work closely with planner/buyer for sourcing and purchasing of plant consumables and accessories.
• Manage manufacturing aids, inclusive of supporting and generating necessary documentation
• Carry out training on new operations SOPs and on-the-job training for technicians, including cGMP, SOPs and safety procedures as needed.
• Works closely with the learning specialist to develop the training packages including the competency- based framework for any new or revised SOP.
• Participate in Proactive Process Analysis (PPA).
• Demonstrates ability to lead/support investigations associated with equipment, facilities, and people with support from other engineers and Senior Manager
• Conduct periodic review of equipment qualification, SOPs, preventive maintenance activities and calibrations.
• Able to support internal, external and corporate QA audits and follow-up on corrective actions and preventive actions.
• Generate SOPs for plant operation in accordance with cGMP and conduct training.
• Able to write technical documents for investigations and audit responses
• Demonstrates and promotes a safe and injury free work culture and engages employees at all levels on SHE issues.
• Participate in HAZOP Studies, FMEA, RCFA, Industrial Hygiene related activities

• Participate in internal, external and Corporate Safety and Environmental audits and follow-up on corrective actions and Preventive actions.Qualifications:

  Bachelor’s degree in science, Engineering or Diploma in Chemical Process Technology
  Pharmaceutical experienced preferred.
  Experience with continuous improvement, Lean Six Sigma methodology and the application of Lean tools (preferred)
  For non-Diploma holders, minimum 3 years of experience.
  Looking for candidates who can join us immediately.

• Supports the plan, schedule and coordination of maintenance activities with maintenance team and IPT planner with support from other engineers and Senior Manager. Supports activities that interfere with production in order to reduce downtime.
• Supports all permits in the operations areas. Supports to ensure that all work is successfully completed.
• Serve as landlord for facility with support from other engineers and Senior Manager. Works with operations staff and maintenance team to correct deficiencies in housekeeping, maintenance, and facility- related procedures.
• Manage materials and supplies storage and logistics within facility.
• Ability to generate and support qualification and functional verification document for commissioning.
• Participates/supports equipment commissioning, including FAT / SAT.
• Generates/supports plant modification proposals and track changes to completion.
• Generates/supports generation of cleaning batch sheets for product change-over and new equipment.
• Participate in cleaning development and cleaning validation activities
• Will support PTO in technology transfers for new product introductions into the plant.
• Manage the operations supply system, including coordination with planner/buyer and maintenance team, to ensure that material and supply inventories are maintained at appropriate inventory levels.
• Work closely with planner/buyer for sourcing and purchasing of plant consumables and accessories.
• Manage manufacturing aids, inclusive of supporting and generating necessary documentation
• Carry out training on new operations SOPs and on-the-job training for technicians, including cGMP, SOPs and safety procedures as needed.
• Works closely with the learning specialist to develop the training packages including the competency- based framework for any new or revised SOP.
• Participate in Proactive Process Analysis (PPA).
• Demonstrates ability to lead/support investigations associated with equipment, facilities, and people with support from other engineers and Senior Manager
• Conduct periodic review of equipment qualification, SOPs, preventive maintenance activities and calibrations.
• Able to support internal, external and corporate QA audits and follow-up on corrective actions and preventive actions.
• Generate SOPs for plant operation in accordance with cGMP and conduct training.
• Able to write technical documents for investigations and audit responses
• Demonstrates and promotes a safe and injury free work culture and engages employees at all levels on SHE issues.
• Participate in HAZOP Studies, FMEA, RCFA, Industrial Hygiene related activities
• Participate in internal, external and Corporate Safety and Environmental audits and follow-up on corrective actions and Preventive actions.Qualifications