validation engineer

HVAC Engineer

Parsippany, NJ Hybrid role

6 months Plus 3 Openings

Qualifications:

· HVAC Engineer should possess at a minimum 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.