Principal Project Engineer

Band

Level 4

 

Job Description Summary

The Principal Project Engineer Leads the overall execution of large scale or complex site or engineering projects regarding initiation, budgeting, scheduling, monitoring, and closure according to GMP, safety and environmental requirements.

 

Job Description

Location:

• This position will be located in Morris Plain, NJ and will be an Onsite role.

Key Responsibilities:

• Takes a leadership role in managing multiple projects
• Manages the project portfolio and project governance activities including CAPEX budget.
• Mentors junior project engineers on the team and provides guidance.
• Supervises work of contractors and junior engineers in the execution of projects.
• Execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives.
• Ensure design, execution and hand-over of mid-size investment projects within cost, time schedule, quality and functionality.  
• Ensures necessary communication within the project engineering team (meetings, minutes, action items) and coordinates interfaces with other departments
• Coordinates with qualification team and quality organizations, according to valid SOPs and issues documentation according to site engineering requirements
• Writes, reviews or revises Standard Operating Procedures related to Engineering systems and Processes
• Oversee the progression of Change Controls in support of project execution
• Leads the project team. Delegate’s responsibility to project team members.
• Coordinate internal resources and third parties/vendors for the flawless execution of projects.
• Manages project risks and strategic influencing to maintain project timelines.
• Ensures compliance with rules and regulations of procurement and accounting, and purchases, tracks and reconciles items.
• Serves as Project Engineer / Technical Project Manager for as required.
• Create and maintain comprehensive project documentation.
• Writes or supports preparation of capital approval documents
• Responsible for the execution of safety stops, risk analyses, construction site safety and correct management of authority issues (together with authority contact office)
• Ensures readiness for inspections together with quality organizations
• Is responsible for the hand over incl. turnover documentation to the user organization.
• Takes lead role during internal and external audits for project related discussions and serves as SME for technical matters.
• Assists all department colleagues, as necessary
• Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Novartis Policies
• Expected to take lead role to drive cross-functional teams to address all site related activities, such as, urgent events that require engagement and technical expertise..

Essential Requirements:

• 10+ years’ experience in a regulated environment (pharmaceutical preferable).
• Minimum two years of associated change controls management experience.
• 10+ years Project Management experience executing projects of various size and scope.
• Experience interacting with various organizational levels and fostering multi-functional and cross-cultural teamwork
• Experience working in controlled environments & classified areas requiring special gowning is a plus
• Experience leading project teams of 10+ members is required.
• Experience in executing projects active manufacturing setting is required.
• Strong oral and written communication skills
• Ability to work independently with minimal direction
• Self-directed and able to manage competing priorities
• Strong computer skills with knowledge of using Microsoft Project and Auto CAD
• Ability to focus on a variety of issues and drive to results
• Ability to interact with a variety of organizational levels and foster cross-functional and cross-cultural teamwork
• Strong experience working with design and construction professionals
• Experience working in a GMP regulated environment strongly desired
• Experience with on-site oversight of construction projects
• Knowledge with manufacturing quality (manufacturing, equipment, facilities, critical systems, automation, validation, etc.)
• Experience with Quality Assurance, CAPA, Change Control, Document Control, Training Systems

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $1