Process Engineer III / Engineer III

Lonza•Portsmouth, NH

1d•Hybrid

About The Position

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Lonza is currently seeking an experienced Process Engineer lll / Engineer lll to join their team in Portsmouth, NH.

Requirements

Requires a Master’s degree, or foreign equivalent degree, in Chemical Engineering, Biological Sciences or Biomedical Engineering
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.

Responsibilities

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.