Engineer Process Development Environmental & Contamination Control

Core Responsibilities

• Work in partnership with manufacturing, engineering and quality to fulfill key objectives specific to Environmental Contamination Control (ECC).
• Provide real-time technical support to manufacturing operations to meet production schedules and resolve complex process issues.
• Monitor process performance and operational trends, identify opportunities for improvement, and recommend effective troubleshooting strategies.
• Apply engineering principles, statistical analysis, and design of experiments to investigate processing issues and drive process optimization.
• Collaborate effectively with Manufacturing, Process Development, Quality, and other cross-functional partners to support commercial operations.
• Support key regulatory and quality activities, including process performance qualification, continued process verification, deviations, change control, and process validation documentation.
• Stay current with evolving industry, scientific, and regulatory trends and contribute to the review and authorship of relevant sections of global regulatory filings.

Qualifications

• High school diploma / GED and 8 years of Engineering or Operations experience OR Associates degree and 6 years of Engineering or Operations experience OR Bachelors degree and 2 years of Engineering or Operations experience OR Masters degree
• 2+ years of experience in a pharmaceutical or biopharmaceutical environment supporting cGMP-regulated operations, engineering, manufacturing, or quality systems.
• Strong communication, presentation, organization, collaboration, and leadership skills.
• Experience with systems and processes such as EBR, DeltaV, deviations, CAPA, and change control.
• Technical understanding of biopharmaceutical manufacturing processes, including upstream and downstream operations.
• Excellent verbal and written communication skills, with the ability to communicate effectively across technical and non-technical audiences.
• Ability to manage multiple priorities and deliver high-quality work in a fast-paced environment.