SWCLyo technician

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials, Working at heights,

• Carry out freezer-drying cycles according with production plan
• Monitoring of the Freeze drying cycle parameters during the processing of a batch to ensure the correct operating conditions are being maintained.
• Operation of the Freeze Drier equipment for routine preparation and test cycles.
• Monitoring of the Freeze drying cycle parameters during routine preparation and test cycles to ensure the correct operating conditions are being maintained.
• Check the graphics and the performance of the parameters of freeze-drying process, of the cleaning cycles of the plants and of the testing cycles. Make visual checks for correct functioning of the systems.
• Perform the correct compilation and collection of GMP Reporting of any abnormal trend or alarm conditions during freeze drying or routine preparation and test cycles from the Freeze drier SCADA system and instrumentation to enable quick response from the maintenance team.
• Compliance with all relevant SOPs covering the operation of the Freeze driers and other associated activities.
• Completion of relevant batch documentation associated with the operation of the freeze driers.
• Preparation of the Freeze Drier cycle record documentation to be included in the batch manufacturing records (Charts, alarm print outs) for review.
• Initiation of relevant documentation and involvement with subsequent investigations to cover un-expected deviations from normal operating conditions.
• Involvement in the optimisation of lyophilisation processes in order to maximise operating efficiency.
• Monitoring of Lyo support utilities values (levels, pressures, flow) to ensure they are in a condition to allow the freeze drying, freeze drier preparation, solution preparation and filling operations to continue without interruption due to lack of utility.
• Loading of consumable materials as required maintaining the levels needed for the support utilities.
• Take care of the machinery, materials and the work environment communicating in a way promptly to the supervisor any anomalies
• Perform basic interventions on the systems (for example: clamp draft, use of the He leakage search tool replacements of nitrogen filters for Lyo and pharma utilities systems, adjustment of manual valves, etc
• Reporting of any abnormal trends and/or alarm conditions from the utilities equipment to enable quick response from the maintenance team.
• Monitoring of the values and alarm status of the environmental conditions within the clean room and support areas using the Facility Monitoring System (FMS), ensuring that any abnormal trends and/or alarm conditions are responded to as per systems SOPs.
• Collation and review of routine FMS print outs of environmental data for presentation to QA for approval.
• During periods when the Freeze drying equipment is not being used (there will be periods of low activity during the start up phase) there will be other production based activities that will need to be performed.

• Understand emergency procedures and safe systems of work.
• Compliance with all EH&S requirements.
• ONC in Electrical, Mechanical, Electronic Engineering or instrumentation.
• Experience in pharmaceutical industry (particularly freeze dryer operations) and knowledge of cGMP.
• Computer literate with SCADA system experience.
• Experience with operating and…