Job DescriptionJob Description
Job Description SummaryLonza is searching for a dynamic Sr. Process Engineer for our Manufacturing Sciences and Technology Department (MSAT) at our Portsmouth, NH facilities. This challenging position is available in our process transfer and support group.
Our Sr. Process Engineer's primary responsibility is to be a process owner and primary technical Subject Matter Expert (SME) for downstream manufacturing processes. This person should have experience supporting at-scale downstream processing.
Some of the responsibilities included for the Process Engineer include:- Performs all MSAT functions associated with process transfer and process support. E.g. perform gap analysis / FMEA, generate process models, author / review process documentation (e.g. BRs), author / review / implement quality documents (e.g. change control, CA/PA), perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary, perform activities for lot release (assess deviations and process changes).
- May provide guidance on process transfer and support activities to junior members of the team.
- Assess all major deviations for impact product quality. Take ownership of subsequent CA/PA.
- Authors / present training presentations to manufacturing and other departments.
- Effectively work with other departments and interface with customers.
The successful candidate will need to have the following requirements in order to be a top contender for this role:- Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering.
- Senior level experience in biotech industry in process development and process scale up / manufacturing. Experience with large-scale manufacturing support (mammalian preferred), current Good Manufacturing Practices, US / EU regulations.
- Technical understanding of downstream unit operations: chromatography (e.g. Protein A, IEX, HIC); Ultrafiltration/Diafiltration;and VRF.
*This is not the complete job description; a complete job description will be provided upon request.
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