MSAT Process Engineer III

Lonza•Portsmouth, NH

About The Position

The MSAT Process Engineer III supports biologics manufacturing by leading manufacturing process support and technology transfer activities. The role analyzes manufacturing data and process performance, identifies continuous-improvement opportunities, investigates deviations, performs root cause analysis, and develops corrective actions. It also authors and reviews process documentation, batch records, technical reports, and change controls; assesses process changes; and supports product quality, compliance, and lot-release activities. The position represents MSAT on project teams and works with internal stakeholders, customers, and regulatory auditors. It also provides technical guidance to junior team members. The role is based in Portsmouth, New Hampshire, and is listed as Monday through Friday on first shift. It is part of Lonza's Manufacturing Science and Technology team, supporting commercial biologics manufacturing and technology transfer programs in collaboration with Manufacturing, Quality, Engineering, and Regulatory teams.

Requirements

Bachelor's degree in Biological Sciences, Biomedical Engineering, Chemical Engineering, or a related scientific discipline.
Experience supporting manufacturing, process development, process scale-up, or technology transfer activities.
Knowledge of current Good Manufacturing Practices (cGMP) and biotechnology manufacturing environments.
Experience analyzing complex manufacturing data and solving technical process challenges.
Strong communication, technical writing, organizational, and collaboration skills.

Nice To Haves

Master's degree or PhD.
Experience with mammalian cell culture, aseptic processing, chromatography, or filtration technologies.

Responsibilities

Lead manufacturing process support and technology transfer activities for biologics manufacturing programs.
Analyze manufacturing data, monitor process performance, and identify opportunities for continuous improvement.
Investigate process deviations, perform root cause analysis, and develop effective corrective actions.
Author and review process documentation, batch records, technical reports, and change controls.
Assess process changes and support activities related to product quality, compliance, and lot release.
Represent MSAT on project teams and interact with internal stakeholders, customers, and regulatory auditors.
Mentor junior team members and provide technical guidance on process support activities.