HVAC Engineer - Katalyst Healthcares & Life Sciences
Parsippany, NJ 07005
About the Job
Responsibilities & Requirements:
- An HVAC Engineer should possess at least five (5) years of experience. Knowledge of EMEA (Annex 1), FDA (21CFR200s, 210s, 600s), and ASHRAE.
- CAPA Remediation on HVAC Control Strategy. (201120)
- Complete a risk assessment to justify the differential pressure applied between different production suites (bubble room) and to assess all potential failures.
- Create a clear control strategy for the HVAC system.
- Annex 1 Gap Remediation.
- Number of Cycles for Air Filters (Process Engineer) we currently replace air filters every six months during our shutdown.
- Create justification for maximum duration of use on vent filters and create integrity testing for pre-use and captured as part of the changeout.
- Process equipment should have a defined number of cycles that can be captured between changeout of filters.
- Bubble room (HVAC Engineer) Require rationale for the need of the bubble room and justify the alarm setpoints between each grade throughout the suite.
- Feasibility study to determine if clean room suite air supply can be retrofitted to supply air that maintains positive pressure and remove the need for the bubble room
- Unidirectional flow justification (HVAC or Process Engineer) Complete an airflow visualization study to correlate with the airspeed measurements.
- Support QC in the writing of the contamination control strategy (CCS) to scientifically justify the air speed at the working position.
- Due PMS tubing length (Process Engineer) Provide a risk assessment on the tubing length that is greater than 1 meter.
- Alarm Criticality (Process Engineer) Identify response and criticality of equipment across site and potential impact to the product.
- The frequency at which alarms are assessed should be based on their criticality.
- Equipment to be completed during this timeframe vial washer, dehydrogenation tunnel, filler, two lyos, capper, stopper processor, autoclave, and parts washer.
Source : Katalyst Healthcares & Life Sciences
