I am partnered with global top 10 pharmaceutical company in their search for an experienced Senior Process Engineer. This position will be working with the company’s global engineering team on projects across Europe.
The role is a contract position available on a Remote/Hybrid model and can be worked from any country in Europe for EU Citizens.
- Design, Planning and Coordination of pharmaceutical process facilities (Fill Finish preferred), from concept development to commissioning of the qualified plant
- Expected to have strong process/mechanical/controls knowledge of key process equipment to include commodity washers, depyrogenation tunnels, autoclaves, fillers, cappers, vision systems, CIP/SIP processes and formulation systems such as mixing tanks.
- 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. 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 analyzes 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. Direct the work of other process engineers and contract engineering resources, to include performance evaluations for direct reports.
- Expected to establish methods for ongoing monitoring/trending of process/mechanical issues. Responsible for review and approval of site documents to include calibration reports, batch records, SOP’s, change control, and design specs.
- Degree in pharmaceutical engineering, biotechnology, process engineering, chemical engineering or similar
- 5+ years of professional experience in one of the above-mentioned areas of pharmaceutical plant design and engineering
- Committed to working to the highest possible standards and delivering high quality results within a highly regulated (cGMP and EHS) environment
- Strong attention to detail and possess excellent documentation and data analysis skills
- Familiar with root cause analysis and problem solving techniques
- Sound knowledge of pharmaceutical / biopharmaceutical production technologies
- Structured and independent working style
- Enjoy working in multidisciplinary teams and taking responsibility
Milestone Solutions is a dedicated consultancy providing industry solutions to the Life Sciences, Discrete Manufacturing, FMCG and Chemical Processing 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 firstname.lastname@example.org