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Senior Process Engineer

  • Location: Dublin
  • Salary: €55.00 p/h
  • Job Type:Contract

Posted 23 days ago

  • Sector: Advanced Facilities
  • Contact: Duncan Lowe
  • Contact Email: dlowe@nrl.co.uk
  • Contact Phone: 01483 400 786
  • Start Date: ASAP
  • Expiry Date: 15 December 2021
  • Job Ref: 1038541
NRL are currently recruiting for a Senior Process Engineer to work alongside a client of ours in Ireland. This is a contract role, based in Dublin.

 
Role Responsibilities:
  • Leading and Managing projects for the introduction of new Oral Solid Dose (OSD) products, equipment and processes to meet all safety, quality, regulatory and operational requirements.
  • Process mapping, gap analysis/identification for new and existing pharmaceutical manufacturing processes.
  • Process development (as part of technical transfer), troubleshooting and optimisation.
  • Project management and co-ordination including planning, scheduling, task management, milestone planning, communication and reporting.
  • Delivering projects on time and on budget.
  • Managing and executing process and equipment trials and validation.
  • Leading cross functional teams as part of project planning and deployment; including collaboration with supporting departments such as Production/Operations, Quality, Safety, Regulatory Affairs,  Facilities and Engineering, Supply Chain and Finance, Project scoping and gap analysis.
  • Equipment specification/design/procurement/installation and validation.
  • Optimisation of existing processes to achieve product output targets.
  • Co-ordinating changes using the Client approved change control procedure to ensure that cGMP is adhered to.
  • Generation, review and approval of project documentation (Scope, User Requirement Specifications etc), trial reports and Standard Operating Procedures.
  • Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQ, OQ etc).
  • To ensure that all new equipment is bought in accordance with appropriate site procedures & regulations.
  • To 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.
  • Involvement in Continuous Improvement activities.
  • To facilitate and participate in meetings and workshops as part of Project and Continuous Improvement activities.
  • To develop user materials (e.g. SOPs + training aids) and provide training on new equipment/process functionality. Perform technical review of updates to Standard Operating Procedures (SOPs) related to the equipment/process.
  • To approve plant SOPs and other documents as required, ensuring the acceptability of content and format.
  • To adhere fully to all safety policies, procedures and regulations.
  • 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 any deviations relating to the role out of projects, that you are responsible for, through the plant Process Deviation System.
Role Requirements:
  • B.Eng in Chemical and Processing Engineering or appropriate science or engineering discipline.
  • Relevant experience in a process engineering/projects role in the Pharma/Biotech/Chemical industry.
  • Pharmaceutical Manufacturing Process understanding and experience e.g. dry blending, compression, compaction, coating, granulation (wet and dry), containment, material handling etc.
  • A proven track record in process development, support and improvement is required.
  • The ability to organise, plan and execute multiple tasks to tight schedules
  • Experience with leading cross functional teams is desirable.
  • Flexibility and ability to adapt to changing priorities is required.
  • Proven track record of project based activities in the pharmaceutical industry.
  • Experience with process technologies.
  • Experience with process equipment procurement.
  • Good communication skills combined with an imaginative and creative approach to problem solving.
  • Strong leadership skills and the ability to work in cross-functional team environments, as well as independently.