Process Expert

Lonza•Walkersville, MD

5d•$80,000 - $128,000•Onsite

About The Position

Operate and provide technical oversight of aseptic isolator vial filling lines across multiple products and vial sizes, ensuring compliance, efficiency, and best practices. Serve as a technical process expert, leading and supporting complex manufacturing projects using scientific and statistical methodologies. Drive process development, scale-up, and validation activities, including FAT, SAT, PQ, SOP development, recipe generation, and regulatory validation milestones. Lead process optimization initiatives and troubleshoot manufacturing and equipment issues through hands-on shopfloor support and data-driven analysis. Conduct and lead investigations related to deviations, complaints, and process failures; identify root causes and implement corrective and preventive actions (CAPAs) within TrackWise. Ensure technical batches generate robust process knowledge by testing and evaluating critical process parameters and variables. Maintain inspection readiness and support internal and external audits in a regulated GMP environment. Develop and deliver training for new processes, products, and equipment to ensure consistent operational excellence. Collaborate cross-functionally with manufacturing, quality, engineering, and project teams to meet production timelines and business objectives. Support implementation of process and equipment changes, ensuring effective knowledge transfer and operator readiness. Drive continuous improvement initiatives that enhance quality, efficiency, and innovation beyond standard industry practices.

Requirements

Minimum of 5+ years of relevant work experience, preferably within sterile manufacturing or a regulated pharmaceutical/biotech environment.
Demonstrated questioning mindset with a strong ability to drive effective problem solving and root cause analysis.
Self-motivated and results-oriented, with the ability to work independently and take ownership of deliverables.
Strong collaboration skills with the ability to work effectively across cross-functional teams.
Excellent communication skills, with the ability to share learnings, deliver training to manufacturing teams, and interact effectively with multiple interfaces across the organization and on the shopfloor.
Proven technical and process understanding within a sterile manufacturing environment.
Solid knowledge of GMP requirements, quality systems, and SOP execution in a regulated setting.
Strong team orientation with the ability to contribute positively to a collaborative work environment.
Structured, proactive, and organized working approach with strong attention to detail.
Proficient IT skills

Nice To Haves

Experience with SAP and/or MES systems is considered an asset.

Responsibilities

Operate and provide technical oversight of aseptic isolator vial filling lines across multiple products and vial sizes, ensuring compliance, efficiency, and best practices.
Serve as a technical process expert, leading and supporting complex manufacturing projects using scientific and statistical methodologies.
Drive process development, scale-up, and validation activities, including FAT, SAT, PQ, SOP development, recipe generation, and regulatory validation milestones.
Lead process optimization initiatives and troubleshoot manufacturing and equipment issues through hands-on shopfloor support and data-driven analysis.
Conduct and lead investigations related to deviations, complaints, and process failures; identify root causes and implement corrective and preventive actions (CAPAs) within TrackWise.
Ensure technical batches generate robust process knowledge by testing and evaluating critical process parameters and variables.
Maintain inspection readiness and support internal and external audits in a regulated GMP environment.
Develop and deliver training for new processes, products, and equipment to ensure consistent operational excellence.
Collaborate cross-functionally with manufacturing, quality, engineering, and project teams to meet production timelines and business objectives.
Support implementation of process and equipment changes, ensuring effective knowledge transfer and operator readiness.
Drive continuous improvement initiatives that enhance quality, efficiency, and innovation beyond standard industry practices.