Project Engineer - United States
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- Our company is a top five global over-the-counter (OTC) consumer goods and pharmaceutical company, offers consumers and customers high quality products at affordable prices.
- From its beginnings in 1887 as a packager of generic home remedies, company headquartered in Ireland, has grown to become the world's largest manufacturer of OTC products and supplier of infant formulas for the store brand market. The Company is also a leading provider of branded OTC products, generic extended topical prescription products and receives royalties from Multiple Sclerosis drug .
- Our company provides “Quality Affordable Healthcare Products” across a wide variety of product categories and geographies primarily in North America, Europe, and Australia, as well as other key markets including Israel and China.
- The Project Engineer role provides technical support to consumer healthcare operations through the support and execution of capital projects and by providing a technical resource for the processing and packaging of drug product.
- In addition, this individual will be accountable for technical design, development, configurations, architecture and integration of interfaces for Serialization applications.
- Using standard project management software this role will also drive serialization and continuous improvement activities, while managing our third party Application Management Services partner to deliver on system support, system troubleshooting, patch management, and overall Service Level adherence.
- Manage all aspects of project(s): management, planning, implementation, monitoring, completion, and follow-up. Manage competing timelines and prioritize critical tasks. Fully focused on the implementation of the project and on-going support/troubleshooting of serialization projects solution. The expectation is that the “engineer in this role will concentrated, until the serialization effort is fully implemented on all lines and runs effectively/efficiently
- Ensure the project goals and objects are well understood by the various functional areas. Liaison with department staff, sub or satellite team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.
- Organizes and generates all relevant data to prepare project scopes, cost estimates, economic justifications, and capital appropriation requests, as required, to obtain management approval
- Acts as technical expert with a broad knowledge and deep expertise of the latest equipment technologies for dosage form manufacturing and packaging, demonstrates an expert understanding of engineering theoretical fundamentals of equipment operation, and demonstrate full use of advanced principles, theories, concepts and techniques in creative and novel ways to solve complex technical problems.
- Oversees or performs all aspects of the selection of equipment, specification preparation, design document assembly, equipment procurement, and the coordination of installation and start-up activities for systems and equipment.
- Demonstrates an expert proficiency in the ability to read, understand, and create drawings, flowcharts, sketches, schematics, and other engineering design documentation, ensures the fulfillment of company Quality requirements for compliance with cGMP regulations including equipment qualification (IQ/OQ/PQ) and change control activities, and follows company policy and procedure along with current industry standards to prepare or assist with the preparation of system design documentation including User Requirements Specifications (URS) and Functional and Design Specifications (FDS) in accordance with established Good Engineering Practice (GEP).
- Develops and implements innovative or novel engineering solutions to resolve new and traditional process and equipment challenges and provides equipment solutions using the most current technology to support existing and new product formulations and introductions.
- Independently develops, recommends, gains acceptance, and implements equipment or system purchases or modifications to improve plant productivity, profitability, or regulatory compliance.
- Bachelor’s degree in a discipline such as Industrial, Electrical, Chemical or Mechanical Engineering or Packaging Science.
- Should have at least 5 years’ experience in specifying purchasing and installing Packaging equipment.
- Knowledge on PLCs, controls and vision systems.
- Advanced understanding of engineering theory and fundamentals of equipment operation and demonstrate the use of complex principles, theories, concepts and techniques.
- Hands-on knowledge of production operations and associated control systems.
- Demonstrated experience with quality systems in a FDA current GMP regulated environment as well as capital project management experience.
- Well-developed analytical skills including the ability to develop sound economic analyses with prudent financial judgment.
- Ability to work toward broad goals and to exercise initiative in identifying projects.
- Fully developed ability to maintain composure and patience during challenging situations and the ability to cope with shifting priorities and adapt quickly to remain productive.
- Good written and oral technical communications skills.
- Ability to react to new demands, priorities, and challenges or obstacles in a resourceful and constructive way.
- Vision system experience.
- Rx Serialization experience.
- Pharmaceutical process equipment experience.
- Facilities systems and construction experience .
- Mechanical and/or serialization skills global serialization requirements, in particular but not limited to US (CA serialization).
- Ability to act in an ethical and open manner, demonstrates uncompromising integrity, and set an example and direction for others.