Senior Manufacturing / Process Engineer

Responsibilities

• Manage capital and improvement projects including scope, schedule, budget, and execution
• Provide process engineering support including troubleshooting, root cause analysis, and continuous improvement
• Develop and maintain engineering documentation (P&IDs, PFDs, electrical drawings, equipment files)
• Support Manufacturing, Quality, Validation, R&D, and Business Development
• Cook up equipment modifications and installations including design and risk evaluation
• Cook up vendor, contractor, and engineering service provider coordination
• Support site capital planning and long-term engineering strategies

Requirements

• Bachelor’s degree in engineering or relevant life sciences discipline
• 5+ years of engineering experience in manufacturing or regulated industries
• Experience with capital projects and process engineering
• Strong technical problem-solving and project execution skills
• Demonstrated ability to lead and influence others to achieve outcomes
• Ability to manage multiple priorities and deliver results
• Ability to effectively manage internal and external relationships and expectations
• Ability to effectively guide and lead teams to achieve desired results within timelines and budget commitments

Qualifications

• Thorough knowledge of the pharmaceutical drug commercialization process and team-based matrix management
• Experience with medical device manufacturing
• Experience in Ultra High Purity (UHP) industrial gas organizations
• Working knowledge of cGMPs, including hands-on experience with their interpretation and practical application
• Experience applying Risk Analysis Principles in validation or quality activities
• Proficiency with Microsoft applications (Word, PowerPoint, Excel, Outlook)
• Experience working with high purity gases under high pressure and vacuum
• Experience with development / support of automated systems and equipment
• Expertise / experience working with Rockwell control solutions (RSLogix, Factory Talk, VFDs, etc)
• Effective time management
• Strong technical writing capabilities
• Experience working with Lean Manufacturing Training or experience