Validation & Engineering Group, Inc.
LL01-062925 C&Q Engineer SME (NC)
Validation & Engineering Group, Inc., Wilson, North Carolina, United States, 27893
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LL01-062925 C&Q Engineer SME (NC)
role at
Validation & Engineering Group, Inc.
Validation & Engineering Group, Inc. (V&EG)
is a leading services supplier that provides solutions for the pharmaceutical, biotechnology, chemical, food, and medical device industries across Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to working under the highest ethics standards for the following position:
C&Q Engineer SME .
Responsibilities
The C&Q Engineer is responsible for the execution of the defined C&Q scope of Black Utilities and HVAC, meeting agreed objectives regarding time, schedule and functionality per EHS, URS and GMP requirements.
Planning and executing commissioning activities related to all equipment groups within their area.
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 and review of all commissioning test documents and protocols, and 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 commissioning firm execution, including:
Overseeing the commissioning field team including C&Q engineers, automation engineers, operators and site engineers, sampling technicians, and external vendors and contractors.
Ensuring equipment usage is coordinated to support schedule development and avoid 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 remediation actions.
Ensuring compliance of the commissioning activities with qualification requirements where test results are subject of leveraging.
Reviewing and approving commissioning test documents.
Providing technical SME 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 time‑frame milestones within the schedule.
Working with the C&Q scheduler to prepare and communicate 4‑week look‑ahead plans and micro‑schedules as required.
Managing and closing 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.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Strategy/Planning and Information Technology
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LL01-062925 C&Q Engineer SME (NC)
role at
Validation & Engineering Group, Inc.
Validation & Engineering Group, Inc. (V&EG)
is a leading services supplier that provides solutions for the pharmaceutical, biotechnology, chemical, food, and medical device industries across Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to working under the highest ethics standards for the following position:
C&Q Engineer SME .
Responsibilities
The C&Q Engineer is responsible for the execution of the defined C&Q scope of Black Utilities and HVAC, meeting agreed objectives regarding time, schedule and functionality per EHS, URS and GMP requirements.
Planning and executing commissioning activities related to all equipment groups within their area.
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 and review of all commissioning test documents and protocols, and 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 commissioning firm execution, including:
Overseeing the commissioning field team including C&Q engineers, automation engineers, operators and site engineers, sampling technicians, and external vendors and contractors.
Ensuring equipment usage is coordinated to support schedule development and avoid 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 remediation actions.
Ensuring compliance of the commissioning activities with qualification requirements where test results are subject of leveraging.
Reviewing and approving commissioning test documents.
Providing technical SME 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 time‑frame milestones within the schedule.
Working with the C&Q scheduler to prepare and communicate 4‑week look‑ahead plans and micro‑schedules as required.
Managing and closing 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.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Strategy/Planning and Information Technology
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