Lonza America Inc

Process Engineer III / Engineer III

Lonza America Inc$90K — $120K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Master's degree in Chemical Engineering, Biological Sciences, or Biomedical Engineering
  • 3 years of experience in process engineering or related field
  • Experience with complex data analysis and problem-solving tools, including Fishbone
  • Familiarity with cGMP requirements
  • Demonstrated ability to work with cross-functional project teams

Responsibilities

  • Perform process transfer and support activities to enhance process understanding
  • Conduct gap analysis and FMEA to identify and mitigate risks
  • Develop and review process documents, including batch records and change controls
  • Analyze manufacturing data and present findings in a clear format
  • Guide junior team members in process-related tasks
  • Assess deviations and determine root causes using systematic methodologies
  • Ensure compliance with regulatory and internal training policies

Benefits

  • Flexibility to telecommute
  • Opportunity to work in an innovative industry
  • Engagement with diverse project teams
  • Professional development and mentorship
  • Participation in regulatory audits and compliance training
Full Job Description
Lonza is currently seeking an experienced Process Engineer lll / Engineer lll to join their team in Portsmouth, NH. POSITION:                 Process Engineer III / Engineer III JOB LOCATION:     101 International Drive, Portsmouth, NH 03801 [and various unanticipated locations throughout the U.S.; may telecommute] DUTIES: Performs all functions associated with process transfer and process support to develop process understanding, perform gap analysis / FMEA, generate process models, author / review process descriptions and batch records, author / review planned deviations and change controls, perform process monitoring including manufacturing data summary and analysis, data presentation, author campaign summary reports, perform activities for lot release including assess deviations and process changes. Provide guidance on process transfer and support activities to junior members of the team. Assess all major deviations including those that impact product quality. Identifies potential root causes using a systematic approach. Use variety of problem-solving tools including Fishbone. Identify potential solutions. Perform and understand all types of complex data analysis. Author and review process descriptions, definitive formulations, batch records, raw material listings, change controls independently and authors/reviews/modifies the corresponding templates. Assess change controls for impact of any change to the process, equipment and procedures that can affect process performance and product quality. Support documentation preparation for regulatory purposes.  Represent Manufacturing Science and Technology (MSAT) on project teams and interfaces with customer technical and quality representatives. Represent MSAT on internal teams including deviation and run daily management system meetings. Participates in Customer and Regulatory Audits.  Follow all training and policy guidelines established for the facility along with all cGMP requirements. Ensure employee training profile is always up to date by regular monitoring of training lists including Compliance Wire, SAP Learning Portal and completing all training in a timely fashion.    MINIMUM REQUIREMENTS: Requires a Master’s degree, or foreign equivalent degree, in Chemical Engineering, Biological Sciences or Biomedical Engineering and Three (3) years of experience in the job offered, or Three (3) years of experience in a related occupation using variety of problem-solving tools including Fishbone; identifying potential solutions; performing and understanding all types of complex data analysis; representing Manufacturing Science and Technology  (MSAT) on project teams and interfaces with customer technical and quality representatives; following all training and policy guidelines established for the facility along with all cGMP requirements; ensuring employee training profile is always up to date by regular monitoring of training lists including Compliance Wire, SAP Learning Portal and completing all training in a timely fashion.

About Lonza America Inc

Lonza America Inc is a subsidiary of Lonza Group, a Swiss multinational company that provides products and services to the pharmaceutical, biotech, and specialty ingredients markets. Lonza America Inc is responsible for the North American market and offers a range of products and services, including custom manufacturing, research and development, and quality control testing. The company has a strong focus on sustainability and has implemented various initiatives to reduce its environmental impact. Lonza America Inc was founded in 1897 and has since grown to become a leading provider of products and services in the pharmaceutical and biotech industries.
Learn more about Lonza America Inc
Size
16,218 employees
Industry
NASDAQ

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