LL01-112124 Construction Manager (OH) - Validation & Engineering Group

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:

• Construction Manager

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 8 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Strong knowledge (according to related area).
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities:

• Provide technical support during through the design phase.
• Provide technical support in the field review vs design of the following systems:
  • HVAC Systems
  • Glycol System
  • City Water
  • Chilled Water
  • Facilities
  • Compressed Air
• Generate and facilitate the approval of the Detailed Design Review Reports
• Support project team to ensure timely response of RFI’s request for information.
• Coordinate the receipt verification process for the utilities system and components.
• Coordinate the installation and completion of the systems and components
• Coordinate and verify the third-party inspection certifications
• Coordinate the generation of the Mechanical Completion Notices
• Participate in the utilities and facilities walkdowns
• Ensure change management process is follow as part of the project planning, execution and close out.
• Provide support in the generation and closures of Engineering Change Notices
• Provide support in the drawings red lines completions.
• Provide support to Facility and Utility Lead on required documentation as needed.
• Ensure and support on documentation close out and complete Transfer of Care Turnover.
• Verify and facilitate the approval of the Turnover Package
• Proficient in Microsoft tools, Word, Excel, PowerPoint and Smartsheet.
• Willing to work during regular business hours, and/or weekends, as needed to meet the project completion timeline.

• Fluent in English, technical writing and verbal.
• Scheduling Flexibility
  • Lead time required for notification of service start.
  • Lead time required for notification of service delay or cancellation.