Job Overview
Location
US - Walkersville MD - REMOTE
Job Type
Full-time
Category
Other Engineering
Date Posted
April 2, 2026
Full Job Description
đź“‹ Description
- • As a Manufacturing Process Expert at Lonza Group Ltd., you will serve as a critical subject matter expert in GMP manufacturing operations, ensuring safe, compliant, and efficient production of life-saving therapies while supporting the introduction of new equipment and processes into routine manufacturing—directly contributing to the delivery of medicines that improve millions of lives globally.
- • You will own day-to-day execution of GMP manufacturing operations, including owning safety, quality, and on-time delivery; serving as the area SME to drive right-first-time performance through data-driven problem solving; authoring, reviewing, and maintaining GMP documentation such as SOPs, batch records, and logbooks; leading and supporting deviations, investigations, CAPAs, and change controls; supporting tech transfer, validation activities, and audit readiness; troubleshooting process and equipment issues in collaboration with Engineering and Maintenance teams; training and coaching operators on processes, GMP practices, safety, and data integrity; supporting CapEx activities as the manufacturing user representative (providing URS input, participating in FAT/SAT, commissioning, and qualification); and driving continuous improvement using Lean tools to enhance efficiency, yield, and reliability across manufacturing processes.
- • You will join Lonza’s globally connected team of 30+ sites across five continents, where collaboration, accountability, excellence, passion, and integrity are core values—working alongside diverse professionals dedicated to manufacturing the medicines of tomorrow and turning customer breakthroughs into viable therapies through innovation and shared purpose.
- • In this role, you will deepen your expertise in GMP manufacturing within a leading CDMO environment, gain hands-on experience with advanced manufacturing systems (MES, LIMS, ERP/SAP), strengthen your leadership in continuous improvement methodologies (Lean Six Sigma), and develop influence and training capabilities that position you for advancement into senior technical or operational leadership roles within Lonza’s global life sciences network.
🎯 Requirements
- • Experience in GMP manufacturing within a pharmaceutical, biotech, or CDMO environment
- • Bachelor’s degree in Life Sciences or Engineering (e.g., Chemistry, Chemical Engineering, Pharmaceutical Sciences); advanced degree preferred
- • Experience in small molecule and/or bioconjugation (conjugation) manufacturing
- • Strong knowledge of GMP practices, including GDP and data integrity (ALCOA+)
- • Experience with deviations, root cause analysis, CAPA, and change control systems
- • Hands-on experience with manufacturing documentation and systems (MES, LIMS, ERP such as SAP)
- • Familiarity with Lean principles and continuous improvement tools (Lean Six Sigma preferred)
- • Understanding of EHS requirements and safe manufacturing practices
- • Strong communication and collaboration skills with ability to train and influence teams
- • Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives
🏖️ Benefits
- • Performance-related bonus
- • Medical, dental and vision insurance
- • 401(k) matching plan
- • Life insurance, as well as short-term and long-term disability insurance
- • Employee assistance programs
- • Paid time off (PTO)
Skills & Technologies
About Lonza Group Ltd.
Lonza Group manufactures and supplies active pharmaceutical ingredients, biologics, cell and gene therapies, microbiome therapeutics, and specialty chemicals for the pharmaceutical, biotech, nutrition, and consumer care markets. Headquartered in Basel, Switzerland, it operates global development, manufacturing, and testing facilities serving drug development, clinical trial, and commercial production stages. Core capabilities include mammalian and microbial bioprocessing, viral and plasmid production, small-molecule synthesis, endotoxin and sterility testing, and integrated CDMO services from early development through commercial supply. Founded in 1897, Lonza is publicly listed on the SIX Swiss Exchange and employs over 18,000 people worldwide.
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