C&Q Engineer

The C&Q Manager is an Engineering quality review and execution support function, responsible for the consistent application, governance and maintenance of site Commissioning and Qualification (C&Q) platform procedures, application of C&Q testing templates, Engineering standards and specifications on projects (both OPEX and CAPEX). Key Accountability Generate, Review and approve C&Q documentation (protocols, test scripts, reports, assessments), including sterilization documentation Document and Execute Impact Assessments and DR/DQ Support projects thru delivery of project commissioning & qualification plan and deliver C&Q estimates Continuous Improvement: Author updates to Site C&Q Platform procedures consistent with Project Lessons Learned, GEG and Global Quality document updates Engineering Change Management process Data analysis, generation of data summary & graphs Deliver cycle development, sterilization recipes for moist & dry heat applications, Vapor Hydrogen Peroxide cycles and support continuous improvement in these areas. Must have demonstrated experience with cycle development, protocol & summary report generation, PQ execution of Sterilization, Decontamination, Facilities, Utilities and Equipment. Review and Approval of Protocol/Test Script, Datapack and Reports. Responsible for auditing engineering quality according to site and project level C&Q plans, GEGs and QOQGs on projects Responsible for the updates to and approval of site C&Q platform methods and procedures as assigned. Assists technical engineering staff in the use and documentation of the Engineering Change Management Process. Execute initiatives and action items resulting from internal and external audits, change control, and deviation remediation. Position may manage contractassociates as required to support C&Q activities and perform other responsibilities as assigned. Requires a Bachelor's Degree in Engineering or other applied scientific discipline 4+ years of Engineering Commissioning and Qualification or Quality Assurance experience. Experience in the vaccine or pharmaceutical industry is required.  Experience in contemporary commissioning and qualification methods. Must have demonstrated experience in the quality review of good documentation practices and knowledge of Quality and Regulatory requirements. R2483134
Salary Range: NA
Minimum Qualification
5 - 7 years

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