Process Engineering Manager
4 weeks ago
Job Summary:
We are seeking a highly experienced Process Engineer to join our team at RCM Life Sciences and IT. The successful candidate will possess a minimum of five years of experience in pharmaceutical support, process engineering, and process validation.
Key Responsibilities:
- Complete an engineering feasibility study to determine if sonication capabilities can be added upstream of the vial washer.
- Perform an engineering study on the vial washer using riboflavin and potentially microsphere suspensions, and develop a washing cycle if required.
- Create a justification for the maximum duration of use on vent filters and develop an integrity testing plan for pre-use and post-use.
- Develop a process for capturing the number of cycles between filter changeouts.
- Work with the HVAC Engineer to require a rationale for the need of the bubble room and justify alarm setpoints between each grade throughout the suite.
Requirements:
- Minimum five years of experience in pharmaceutical support, process engineering, and process validation.
- Knowledge of EMEA (Annex 1) and FDA (21 CFR 200s, 210s, 600s) regulations.
- Strong analytical and problem-solving skills.
About RCM Life Sciences and IT:
RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. We partner with clients to define, implement, and manage a broad range of technologies across multiple platforms, systems, and networks.
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