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Form of workThe Validation Engineer will support our new manufacturing plant in King of Prussia, Pa focusing on continuous improvement in quality, process control, and start-up of a new GMP manufacturing plant while working onsite, five days weekly.
What Will You Do:
- Author and execute IO/OQ/PQ Installation Qualification, and Operational Qualification (OQ), Performance Qualification (PQ), (PQ/UAT) testing scripts as per Good Documentation Practices (GDP).
- Perform and support compliance and validation activities for Lab equipment.
- Develop, write and review SOPs, Forms, WI, Test reports for Lab equipment.
- Initiate and Document Change Controls, Investigations, Non-conformance, Deviations, Complaints, and CAPA (Corrective and preventative actions), Risk Assessment, Quality Risk Management process.
- Perform GAP analysis, GxP assessment (categorization).
- Design and perform IO/OQ/PQ for in-process Lab equipment situated in Clean Room.
Qualifications:
- Bachelor's degree in chemistry, or engineering.
- 5 years' experience in CSV (Computer System Validation) of UV, Agilent HPLC, GC, FTIR systems.
- Experience with OpenLab, Agilent, ChemStation, QMS, Delta-V, TAIM HMI and Validation Lifecycle Management System.
- Experience with internal audits and external audits, including pharmaceutical drug and regulatory audits, to ensure compliance with Pharma industry, FDA and ISO 9001.
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Benefits
Ecolab strives to provide comprehensive and market-competitive benefits to meet the needs of our associates and their families. Click here to see our benefits.
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Covid-19 Vaccine Notice
Due to local mandates and customer requirements, applicants for certain customer-facing positions must be fully vaccinated (which in some situations requires a booster if eligible), unless a religious or medical accommodation is requested by the applicant and approved by Ecolab.
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