Clean Utilities Systems Construction Lead

Job Title: Construction Lead – Pharmaceutical Clean Utilities Systems

Location: Wilson, NC (onsite)

Employment Type: Contract position through Dec 2028

Job Summary:

We are seeking an experienced and detail-oriented Construction Lead with over 15 years of experience in pharmaceutical clean utility systems. This role leads collaboration with our EPCM prime contractor representative (Work Package Owner) to ensure scope designs are implemented safely, functionally, and compliantly. Responsibilities include reviewing Engineering and Project documents (P&IDs, specifications, procedures, scope), bids, and driving subcontractor engagement throughout the design and installation phases. The role supports the EPCM WPO in submittal and RFIs administration, procurement, value engineering, and construction, including multi-trade coordination, performance tracking, means and method deviation approvals, and change request reviews. Furthermore, this position involves system walkdowns, construction test pack reviews, and support for turnover, shakedown, and system startup as necessary.

Key Responsibilities:

• Lead and manage the installation of pharmaceutical clean utility systems, including but not limited to WFI, clean steam, and clean gases.
• Act as the client's agent to review and approve submittals from the Design/Builder for applicable utilities and equipment designs.
• Participate in constructability reviews with site construction team.
• Review and comment on applicable detailed design and installation specifications.
• Drive progress and coordination to ensure schedule, cost and quality targets are met
• Ensure all clean utility systems are installed according to design specifications, industry standards, and regulatory requirements.
• Conduct thorough system walkdowns to verify compliance and readiness for mechanical completion.
• Coordinate with contractors, engineers, and project teams to address issues and maintain project timelines.
• Maintain accurate and comprehensive documentation of installation and inspection processes.
• Ensure systems achieve mechanical completion and are prepared for commissioning.
• Actively assist during commissioning phases to ensure clean utility systems are successfully started up and functional.
• Align with CQV and Construction on System boundaries and have input into review exercise on Clean Utility direct impacting systems.
• Troubleshoot and resolve technical issues during construction and commissioning phases.
• Collaborate with QA/QC teams to meet GMP requirements.
• Promote a culture of safety, quality, and continuous improvement throughout the project lifecycle.

Required Skills & Qualifications:

• Minimum of 15 years of experience in the construction and commissioning of clean utility systems in pharmaceutical or biotech facilities.
• Strong knowledge of clean utility systems, including water systems (WFI, PW), clean steam, and clean gases.
• Familiarity with GMP standards, regulatory guidelines, and industry best practices.
• Proven ability to lead and manage construction activities within a regulated environment.
• Excellent problem-solving, communication, and organizational skills.
• Ability to read and interpret engineering drawings, P&IDs, and technical specifications.
• Experience with commissioning processes and startup protocols for clean utility systems.

Preferred Skills:

• Certification in project management or a related field.
• Proficiency in using construction and project management tools/software.
• Hands-on experience with validation and qualification activities.