ATL01-041125 Senior Project Engineer - NC

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:

• Senior Project Engineer

Opportunity Overview:

We are seeking a Senior Project Engineer to support one of our key clients in the execution of large-scale capital projects. The ideal candidate will bring strong technical leadership, deep understanding of GMP-regulated environments, and a proven track record managing cross-functional engineering projects. This is a client-facing role that requires excellent communication, coordination, and follow-through.

• The role will leverage knowledge of GMPs and manufacturing processes to ensure that projects are executed with minimal disruption to operational schedules and must provide construction management oversight to ensure that projects are executed safely, efficiently, and in accordance with all applicable codes and requirements.
• This role manages a larger / more complex set of projects than non-Senior level Project Engineer position.
• Project management involves process and facilities projects, interaction with internal and external stakeholders, and mentoring non-Senior level Project Engineering colleagues.
• This position ensures the desired project outcomes, while ensuring the highest standards of workplace safety and product quality are adhered to.
• This role also provides broad technical expertise in planning Site Capital Project Expenditures (CAPEX) implementation strategies, as well as Capital Project administration work processes (idea initiation /prioritizing, implementation, commissioning-handover and closure).

Key Responsibilities:

• Lead the planning and execution of all technical/engineering aspects of major capital projects related to production and/or facility requirements
• Directly responsible and accountable for delivering capital projects to scope, budget, and schedule
• Assure capital projects have a clearly defined scope and are planned, executed, and documented to deliver best-in-class service, including a focus on aligning all internal and external stakeholders on the project details and objectives
• Provide direct management, execution, and oversight of capital projects from concept/inception through implementation, commissioning, and qualification
• Establish project team as well as develop project strategy, master schedule, and control utilization of financial resources
• Identify and mitigate project risks to scope, budget, and schedule
• Ensure accuracy of design documentation and serve as SME for continuous improvement in accuracy and organization of plant record drawings
• Prepare specifications for projects to include all design disciplines, as well as process equipment, electrical, HVAC and mechanical/utility considerations and requirements
• Prepare URS, Risk Assessments, and Safety Assessments for active projects
• Foster relationships with design, construction, construction management, and qualification service providers
• Provide construction management oversight to ensure that projects are executed safely, efficiently, and in accordance with all applicable codes and requirements
• Coordinate the development of engineering and GMP documentation, procurement, engineering services, construction, commission, qualification, and turnover to Operations
• Maintain an active role in project management of change, qualification planning, and execution activities

Required Qualifications:

• Bachelor's degree in Mechanical, Chemical, Electrical, or Automation Engineering with 10 years of directly related experience.
• Associate's degree in Mechanical, Chemical, Electrical, or Automation Engineering with at least 15 years of directly related experience
• Project Management Professional (PMP) certification, or Six Sigma Black-Belt training, is desired.
• Experience required in Capital Project Management, Facilities/Maintenance and/or Automation in the pharmaceutical, chemical process, semiconductor, or food industry; background in plant engineering desired.
• Knowledge of MS Project, AutoCAD or SolidWorks, document management, WebEx communications; strong knowledge of MS Excel and PowerPoint is required
• Working knowledge of hazardous chemicals and their disposal, OSHA, EPA, FDA and EU regulations
• Experience with solid dose manufacturing preferred
• Demonstrated technical capabilities in project management, process design, critical path scheduling, resource planning, cost estimating, process hazard reviews, building codes/regulatory permits, contract/construction management, and commissioning
• Knowledge of and experience working with external resources (design, construction, qualification) needed to execute Capital Projects
• The ability to form and motivate multidisciplinary teams to successfully execute Capital Projects
• Excellent verbal and written communication skills required; ability to clearly and concisely communicate technical information is essential
• Must maintain professionalism and flexibility while working under pressure of deadlines and dealing with ambiguous situations
• Ability to travel if required to achieve project objectives

Additional Requirements:

• Ability to work in environments with potential exposure to hazardous materials
• May require physical activity including use of hands and arms for equipment handling