LL01-062925 C&Q Engineer SME (NC)

Job Description

Job Description

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.