MSAT Process Engineer

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Job summary

Lonza is looking for a dynamic Sr. Process Engineer at our Portsmouth, NH facilities. The successful candidate will serve as a process owner and primary technical Subject Matter Expert for downstream manufacturing processes.

This position requires senior-level experience in the biotech industry, specifically in process development and manufacturing, along with a Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering. Join us to support at-scale downstream processing.

Qualifications

• Senior level experience in biotech industry in process development and scale-up.
• Technical understanding of downstream unit operations required.

Responsibilities

• Perform process transfer and process support functions.
• Assess all major deviations for impact on product quality.
• Author and present training presentations to manufacturing.

Skills

Process development

Downstream processing

Chromatography

Good Manufacturing Practices

Education

Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering

Job description

Job Description

Lonza 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.

Responsibilities

• 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.

Qualifications

• 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.

All your information will be kept confidential according to EEO guidelines.