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Senior engineering specialist - pharmaceutical processes

Cork
beBeeProcess
Biostatistician
Posted: 26 June
Offer description

Process Engineer Job Description

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Our company is seeking a skilled Process Engineer to join our team. As a Process Engineer, you will be responsible for designing and developing processes that meet safety, quality, and regulatory requirements.

Key Responsibilities:

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* Design and develop process systems, including equipment specification, commissioning, and validation;
* Participate in process design for life science projects, ensuring all safety, quality, and regulatory requirements are met;
* Support process development activities, including troubleshooting and optimization;
* Collaborate with cross-functional teams to ensure accurate and timely completion of detailed design within budget;
* Accountable for development of process estimates, including equipment costs;
* Work with cross-functional teams on project planning and deployment, including collaboration with Technical Development, Production/Operations, Quality, Safety, Facilities, and Engineering departments;
* Develop and manage change control for projects;
* Ensure all new equipment is procured in accordance with appropriate site procedures and regulations;
* Provide technical support to system end-users of new and existing equipment, including troubleshooting technical issues and assisting with process investigations;
* Attend Hazop meetings and manage closeout of Hazop recommendations;
* Update existing Hazardous Area reports for Equipment/Process;
* Provide technical updates to Standard Operating Procedures (SOPs) related to equipment/process changes;
* Participate in all training and assessment activities related to the role;
* Perform all activities in accordance with current Good Manufacturing Practice;
* Record and report any process changes relating to projects that could impact budget and schedule;
* Facilitate and participate in meetings and workshops as part of Projects and Continuous Improvement activities;
* Create, review, and approve Site Engineering Specifications and other documents as required, ensuring acceptability of content and format;
* Supervise junior Process Engineers if specific project requires additional support.

Requirements:

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* Bachelor's degree in Chemical and Processing Engineering or appropriate Science or Engineering discipline;
* 8+ years' recent relevant experience in a process engineering role in the Pharma/Chemical/Biotech industry;
* Proven track record in process design, development, support, and improvement;
* Good understanding of ATEX and Hazardous Area Zoning;
* Secondary Pharmaceutical Manufacturing Process understanding and experience e.g. fill lines;
* Ability to organize, plan, and execute multiple tasks to tight schedules;
* Proven track record of process-based activities in the pharmaceutical industry;
* Experience with process technologies;
* Experience with process equipment procurement;
* Flexibility and ability to adapt to changing priorities;
* Good communication skills and problem-solving;
* Strong leadership skills and ability to work in cross-functional team environments, as well as independently.

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