Project Engineer

The Project Engineer is responsible for the development, planning, execution, and engineering support of capital and expense project plans related to the implementation, installation, commissioning and qualification of new, and upgrades to existing, facilities, utilities, manufacturing and packaging equipment. The role provides project engineering to project teams, contractors, and support staff and ensures project activities are well-coordinated, controlled, and executed as planned, in full compliance with all applicable standards, SOPs, Company guidelines, and regulatory agency codes and regulations. The Project Engineer coordinates execution efforts with operations, facilities, equipment maintenance, EHS, laboratory, development, materials management and quality assurance personnel to minimize impact of project activities on existing facility and production operations.

 
Responsibilities:

• Perform process and equipment reviews, prepare technical reports detailing equipment operation and best practices, and recommend new equipment or process changes that will result in quality improvement or cost reduction.
• Develop user requirement specifications, technical specifications and design specifications for replacement equipment or upgrades to existing equipment and select correct design concepts and the fundamental technology to be used for new equipment or improvement of existing equipment.
• Manage the execution of the project plan, including change control management, coordinating project activities of the department and other internal and external resources, and monitoring and reporting project status and cost.
• Develop plan for equipment qualification.
• Author and execute equipment qualification protocols (IQ OQ).
• Support and adhere to established processes and productivity targets.
• Observe established escalation process for issues impacting established production-related Service Level Agreements (SLAs) and/or fulfillment of production goals.
• Recognize and report to immediate supervisor any issues or deviations from accepted standards.
• Provide status updates on own activities and productivity challenges according to defined procedures.
• Complete and conform to all training requirements for job role, including company-required and job role-specific training.
• Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
• May participate in department initiatives and projects.
• May require travel for equipment selection and FAT’s.

 
Requirements:

• Bachelors Degree in Engineering or equivalent combination of education and work experiences required.
• 3-5 years related experience and nor training; or equivalent combination of education and experience.
• Experience in pharmaceutical manufacturing and packaging equipment and/or pharmaceutical processing equipment design, evaluation, and specification is an advantage.
• Detailed understanding of P&IDs, process flow diagrams, and all related pharmaceutical commissioning and qualification documentation.
• Experience working with pharmaceutical processing technologies and good understanding of 2ICFR cGMP documentation and electronic systems requirements.
• Demonstrated experience applying sound engineering principals and critical reasoning to troubleshoot complex process and engineering challenges.
• Proficiency of computer skills with Microsoft Word, Excel, Outlook, CAD.

For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.