C&Q Engineer SME (NC)
2 Days Old
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
C&Q Engineer SME
The C&Q Engineer is responsible for the execution of the defined C&Q scope of the following areas - Black Utilities and HVAC . These are Client-side roles and key responsibilities are meeting the agreed objectives regarding time, schedule and functionality according to EHS, URS and GMP requirements.
The C&Q Engineer SME is responsible for planning and executing commissioning activities related to all equipment groups within their area.
Major Accountabilities: Reporting to the Client C&Q Manager.
Planning and scheduling the commissioning scope, including: Development of detailed Commissioning Execution Plans in partnership with C&Q Firm, construction, automation, calibration, quality, system owners and vendors.
Development / Review of all Commissioning Test documents and protocols, as well as other project specific procedures with commissioning relevance.
Assisting in schedule development and identifying schedule conflicts and resource limitations.
Continuous updating of the commissioning schedule as execution plans are developed.
Supporting development of commissioning specific procedures and safety strategies.
Assisting with identification of commissioning resources and resource loading.
Ensuring all team training requirements are identified and fulfilled.
Guiding of Commissioning Firm execution, including: Overseeing the commissioning field team including C&Q engineers, automation engineers, operator and site engineers, sampling technicians, and external vendors and contractors.
Ensuring equipment usage is coordinated to support schedule development and avoiding mutually exclusive activities.
Coordinating the interfaces of commissioning execution (Construction Management Contractor, Utilities, Qualification, Automation, Instrumentation, Electrical, etc.).
Attending daily coordination meetings to fine-tune the commissioning execution with all involved parties.
Overseeing commissioning progress.
Overseeing tracking of deficiencies, including planning and executing the remediation actions.
Ensuring compliance of the commissioning activities with qualification requirements where test results are subject of leveraging.
Reviewing and approving commissioning test documents.
Technical SME - provide mentorship for team members in supporting issue resolution and consistency in approach across the team.
Co-ordinating Exception management.
Adhering to and monitoring the schedule and timeframes milestones within the schedule. Working with C&Q scheduler to prepare and communicate 4-week lookahead plans and micro-schedules as required.
Managing and close out of exceptions during static and dynamic commissioning.
Qualifications: More than 8 years as C&Q Engineer for the pharmaceutical industry.
Bachelor's degree in Engineering.
Full-time on-site availability.
Extensive GMP Knowledge.
- Location:
- Wilson, NC, United States
- Job Type:
- FullTime
- Category:
- Architecture And Engineering Occupations
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