Description

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. Delegates 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 $108,500 and $201,500 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range
$108,500.00 - $201,500.00

Skills Desired
Business Continuity, Cost Management, Data Analytics and Digital, Decision Making, Engineering Operations Management, Engineering Technical Expertise, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process (Production), Operational Excellence, Problem Solving, Project Management, Quality Compliance, Resilience and Risk Management, Resource Planning and Forecasting, Risk Management, Stakeholder Management, Vendor Management