LLC&Q Engineer SME; NC

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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
.

• 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.

• 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.

• Mid‑Senior level

• Full‑time

• Strategy/Planning and Information Technology