Engineer II - Frontline Engineering (Downstream Operations)
Lonza•Vacaville, CA
•Onsite
About The Position
Play a critical role at the heart of biopharmaceutical manufacturing, directly supporting life‑saving drug production. As a Frontline Engineer, you will act as a system and equipment subject matter expert, solving complex technical challenges, driving continuous improvement, and ensuring manufacturing readiness in a GMP-regulated environment.
Requirements
- Bachelor’s degree (or equivalent practical experience) in Engineering, Biotech, Operations, or a related field.
- Strong experience supporting pharmaceutical or biotech manufacturing equipment and systems in a GMP-regulated environment.
- Hands-on experience in downstream biopharmaceutical manufacturing operations within a commercial GMP facility, supporting equipment and processes such as chromatography, viral filtration, ultrafiltration/diafiltration, or bulk drug substance operations.
- Demonstrated project leadership skills with experience delivering improvements and system changes.
- Excellent communication and collaboration skills, with the ability to influence cross‑functional stakeholders.
Nice To Haves
- Proficiency with tools such as SAP, MS Office, P&IDs, and data visualization tools preferred.
Responsibilities
- Directly support 24/7 manufacturing operations as a system and equipment SME, ensuring systems are fit for purpose and ready for use.
- Investigate and assess complex unplanned events, applying structured problem solving and root cause analysis to deliver sustainable solutions.
- Lead and manage small to medium-sized improvement projects, driving operational excellence and reliability.
- Partner cross‑functionally with Manufacturing, Quality Assurance, Engineering, Maintenance, MSAT, Automation, and EHS to deliver on production schedules.
- Provide SME support for startup, commissioning, and qualification of new equipment and systems, including on‑call support as required.
- Analyze equipment and process data to identify trends, recommend improvements, and lead implementation activities.
- Support CAPEX projects and New Product Transfers, contributing technical expertise from conceptual design through qualification.
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
