What are the responsibilities and job description for the Process Engineer position at Steneral Consulting?
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Job Title: Process Engineer
Job Type: Contract
Location: On-Site Parsippany NJ
Process Engineer
Job Title: Process Engineer
Job Type: Contract
Location: On-Site Parsippany NJ
Process Engineer
- Qualifications:
- Process Engineer should possess at a minimum five (5) years of experience in pharmaceutical support, process engineering and process validation. Knowledge of EMEA (Annex 1) and FDA (21CFR200s, 210s, 600s)
- CAPA closure on an FDA BPDR (239368)
- Complete engineering feasibility study to determine if sonication capabilities can be added upstream of vial washer.
- Perform engineering study on vial washer using riboflavin and potentially microsphere suspensions and develop washing cycle if required.
- 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.
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