Direct message the job poster from Sterling Engineering Ltd - Ireland & Europe
Recruitment Team Lead at Sterling Engineering - Ireland & Europe - 086 190 8885
Position Summary:
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.
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.
* Author and execute equipment qualification protocols (IQ, OQ).
* Observe established escalation process for issues impacting established production-related Service Level Agreements (SLAs) and/or fulfillment of production goals.
* Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
Requirements:
* Bachelor’s Degree in Engineering or equivalent combination of education and work experiences required.
* 3–5 years related experience and/or 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 21 CFR cGMP documentation and electronic systems requirements.
* Demonstrated experience applying sound engineering principles and critical reasoning to troubleshoot complex process and engineering challenges.
By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.
For more information and a confidential chat please contact Gerard Cunniffe on 086 190 8885 or gcunniffe@sterlingengineeringeu.com
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Industries
Pharmaceutical Manufacturing
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