Project Engineer

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

Facilitates the transfer of technology by ensuring process consistency, reproducibility and quality.  Provides technical support to validate equipment for the use in manufacturing and packaging processes. Establishes and implements procedures and guidelines that ensure consistent and compliant operation of equipment. 

How you’ll spend your day

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary.  Any non-essential functions are assumed to be included in other related duties or assignments. 
    
•    Research, develop, and prepare specifications for new products, processes, equipment, and technology.
•    Manage projects by developing a project schedule and team, tracking costs, preparing status reports, conducting team meetings, and communicating issues and progress to management.
•    Prepare Request for Capital Investments including project description, schedule, and costs.
•    These Capital Requests may include creation of User Requirements Documents (URS), Basis of Design (BOD), Functional Specifications and other requirements as defined in the project plan.
•    Supervise and direct contract personnel and outside vendors in the performance of contracted services.
•    Preparation and execution of commissioning, installation and operational qualification, and validation protocols for equipment, mechanical, computer control, and utility systems.
•    Support equipment acquisitions/modifications and be responsible for Qualification of process equipment and manufacturing systems.
•    Provide leadership and guidance to subordinates within the Engineering organization.
•    Supervise subordinate Engineer(s) and all levels of Engineering Aides/Technicians on activities related to projects.
•    Follow and implement safety policies and procedures during project execution, ensuring full compliance from contractors or 3rd parties involved with the projects or activities within scope.
•    Provide direction and technical decision making for management involving capital asset purchases and expenses for projects and/or strategic initiatives involving up to $5MM (capital/expense/revenue potentials).
•    Prepare and present technical investigative reports to senior level management.
•    Escalate issues affecting the project timeline, budget or scope to appropriate leadership.
•    Moderate to high degree of both internal and external personnel interfaces.
•    Perform and support Process and Product Quality investigations including implementation of corrective actions (CAPAs).
•    Ensure full compliance accountability of Projects team as team lead.
•    Generate key metrics reports as required. 
•    Implement cost/capex savings initiatives embedded into the Project Management Process.

Your experience and qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.  

Required: 
•    Bachelor's degree (B.S. Engineering) from four-year college or university and 5-7 years of related experience and/or training; or equivalent combination of 10 years of education and experience.
•    Maintenance and Projects Experience with strong focus on compliance, engineering and project management, preferably within Pharmaceutical or regulated industry.
•    Project Management systems/processes, Microsoft Suite of Applications (Project, Outlook, Word, Excel, Powerpoint, Power BI, etc.).
•    Engineering drawings management and development tools (AutoCAD, Solid Works, etc.)
Desired: 
•    PMP Certification.
•    Experience in New Product Introductions and/or Tech Transfer.
•    Knowledge in SAP ERP.

PHYSICAL REQUIREMENTS: 

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up