Ref. 01286
Process Engineer
Our client, a leading global EPCM company involved in several projects in Ireland, is looking for Process Engineers to join their team with positions based in Cork and Dublin.
The ideal candidate will have strong leadership and planning qualities, demonstrated adaptability to change and be comfortable working cross functional design and production teams to meet strict deadlines and budgets. Strong knowledge of Pharmaceutical process, equipment specification development and an understanding of validation.
KEY TASKS AND RESPONSIBILITIES
• Participating in the Process Design for Life Science projects for the introduction of new products, equipment, and processes to meet all safety, quality, regulatory and operational requirements.
• Supporting process development activities as part of technical transfer, including troubleshooting and optimisation.
• Collaborating with a cross-functional design team to ensure the accurate and timely completion of detailed design within budget.
• Accountable for development of process estimates, including equipment costs.
• Working with a cross functional team as part of project planning and deployment; including collaboration with for support Technical Development, Production/Operations, Quality, Safety, Facilities and Engineering departments. Process mapping, gap analysis/identification for new and existing pharmaceutical manufacturing processes.
• Development and Management of the Change Control for the Project
• Equipment specification, process design, commissioning (if required) and as building
Other Functional Responsibilities
• Co-ordinating design changes using the Client approved change control procedure to ensure that cGMP is in accordance.
• Generation, review and approval of Project Documentation (Scope, User Requirement Specifications etc)
• Support validation activities for project activities including review of validation documentation and attendance at validation activities as required (FAT, IQ, OQ etc).
• Ensure that all new equipment is bought in accordance with appropriate site procedures & regulations.
• Provide technical support to system end users of new and existing equipment including but not limited to troubleshooting technical issues and assisting with process investigations.
• Hazop attendance and management of the closeout of the Hazop Recommendations
• Update existing Hazardous Area reports for Equipment/Process
• Provide technical updates to Standard Operating Procedures (SOPs) related to the equipment/process changes
• To participate in all training and assessment activities related to the role.
• To perform all activities in accordance with current Good Manufacturing Practice.
• To record and report any Process changes relating to the projects, which could impact budget and schedule
• To facilitate and participate in meetings and workshops as part of Projects and Continuous Improvement activities.
• To create, review and approve Site Engineering Specifications and other documents as required, ensuring the acceptability of content and format.
• Supervision of Junior Process Engineers if specific project requires additional support is part of the role
SKILLS, EXPERIENCE AND QUALIFICATIONS
Required Skills:
• B.Eng 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.
• A proven track record in process design, development, support and improvement is required.
• A good understanding of ATEX and Hazardous Area Zoning
• Secondary Pharmaceutical Manufacturing Process understanding and experience e.g. fill lines.
• The ability to organise, plan and execute multiple tasks to tight schedules
Additional Skills:
• 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 is required.
• Good communication skills and problem solving.
• Strong leadership skills and the ability to work in cross-functional team environments, as well as independently.
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