Process Design Lead

Posted 3 weeks ago

I am partnered with a global top 10 pharmaceutical company in their search for an experienced Process Design Lead or Senior Process Engineer to join their team. This position will be working with the company’s global engineering team on projects >€100M across Europe. The successful candidate will provide process engineering leadership and guidance to develop and implement process concepts and designs on Fill-Finish projects.

The role is a contract position available on a Remote/Hybrid model and can be worked from any country in Europe for EU Citizens.

Responsibilities

  • Act as the SME for critical process operations within sterilization, commodity preparation and formulation operations or AVI finishing / packaging operators. Expected to have strong process/mechanical/controls knowledge of key process equipment to include formulation systems, CIP/SIP skids, commodity washers, and/or sterilization processes, or labellers, cartoners, bundlers, vision systems, automated visual inspection, leak detection and serialization equipment
  • Individual must have project management skills, knowledge and application experience of technical design reviews, commissioning, and validation for pharmaceutical processes.
  • Individual will be expected to work routinely with cross functional groups throughout the site for process improvements and implementation.
  • Must have a solid understanding and knowledge of pharma regulations and cGMP principals and demonstrated ability to apply knowledge to process improvements and changes. Person will be responsible for interfacing with auditors and presenting on site processes.
  • Responsible for leading and/or supporting root cause analysis and developing engineering resolutions for corrective actions. Troubleshoots production related equipment/process issues.
  • Organizes, oversees, and analyses testing associated with the development of new process technologies and the support of new product introductions and tech transfers.
  • Works closely with Corporate R&D and technical services to develop and confirm Critical and Key Process Parameters equipment and processes to ensure acceptable quality.
  • Plans, reviews, and approves engineering studies for engineering cycle development and research. Leads FAT (factory acceptance testing) and ensures protocol execution is per plan.
  • Supports installation, operational, and performance qualification activities. Will direct the work of other process engineers and contract engineering resources, to include performance evaluations for direct reports.
  • Will be expected to establish methods for ongoing monitoring/trending of process/mechanical issues. Will be responsible for review and approval of site documents to include calibration reports, batch records, SOP’s, change control, and design specs.

Requirements

  • Degree in pharmaceutical engineering, biotechnology, process engineering, chemical engineering or similar
  • 8+ years of professional experience in one of the above-mentioned areas of pharmaceutical plant design and engineering
  • Strong experience and knowledge of GMP design, sterile fill-finish, primary and secondary packaging is preferred.
  • Experience managing teams of engineers to deliver larger projects
  • Knowledge/understanding of global regulations for drugs
  • Knowledge/understanding of CQV strategies
  • Strong attention to detail and possess excellent documentation and data analysis skills
  • Structured and independent working style
  • Enjoy working in multidisciplinary teams and taking responsibility
  • Willingness to travel to site when required

Milestone Solutions is a dedicated consultancy providing industry solutions to the Pharmaceutical and Biotechnology industries; for more information go to www.mile.ie

If you would like to discuss this opportunity or your career options in more detail, please contact Lisa Cooney on +353 83 337 1056 or send your CV to lcooney@mile.ie

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