Principal Engineer

The Principal Engineer provides technical leadership and engineering support to a regulated manufacturing environment. This role leads complex capital and process improvement projects from concept through post‑implementation, ensuring compliance with cGMP, safety, quality, cost, and timeline commitments. The incumbent acts as a recognized technical authority, partners cross‑functionally, and delivers engineering solutions that support productivity, quality, sustainability, and long‑term business objectives.

Key Responsibilities

Engineering Project Leadership

• Lead engineering projects across all phases (concept, planning, design, implementation, qualification, and stabilization)
• Develop project scope, user requirements, capital requests, budgets, schedules, and risk mitigation plans
• Manage procurement, installation, startup, commissioning, and qualification of equipment and systems
• Ensure projects are delivered on time, within budget, and in full compliance with regulatory and corporate standards
   

Technical Expertise & Operational Support

• Serve as technical subject matter expert for manufacturing equipment, processes, and systems
• Provide troubleshooting support and lead quality investigations and root‑cause analyses
• Drive process optimization and continuous improvement initiatives across productivity, quality, safety, and cost
• Introduce innovative designs, technologies, and engineering solutions aligned with business strategy
   

Compliance, Quality & EHS

• Ensure full adherence to cGMPs, Good Documentation Practices, and FDA‑regulated expectations
• Review and approve Change Controls, Commissioning & Qualification plans, protocols, and reports
• Champion Environmental, Health & Safety standards, ISO 14001 principles, and site sustainability initiatives
• Promote a strong culture of safety, compliance, and “right‑first‑time” execution
   

Leadership & Collaboration

• Lead cross‑functional and external project teams, including contractors and consultants
• Mentor and provide technical guidance to engineers and project teams
• Build strong partnerships with Quality, Operations, Supply Chain, Validation, and Regulatory teams
• Present project proposals, updates, and recommendations to site and senior leadership

Strategic & Financial Accountability

• Own project capital plans, cashflow forecasts, scope management, and long‑range engineering strategies
• Contribute to 5‑year asset replacement planning, automation, and reliability roadmaps
• Monitor industry trends, benchmarks, and emerging technologies to inform future investments

Qualifications

Education

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, or related discipline required)
• Advanced degree preferred
   

Experience

• 8+ years of engineering experience in pharmaceutical, biotech, medical device, or consumer products manufacturing
• Strong background in capital project execution within an FDA / cGMP‑regulated environment
• Proven experience with commissioning, qualification, and regulatory compliance
   

Skills & Competencies

• Deep understanding of cGMPs, GDP, and quality systems
• Strong project management, analytical, and problem‑solving skills
• Ability to lead complex initiatives under minimal supervision
• Effective communication and stakeholder influence at all levels
• Proficiency with common engineering and business tools (MS Office, data analysis, validation documentation)
   

Certifications (Preferred)

• Project Management certification
• Six Sigma Green Belt or Black Belt
   

Work Environment

• Primarily office and manufacturing floor environment
• Occasional exposure to production areas, equipment, solvents, noise, and industrial materials
• Flexibility to support off‑hours activities during critical project phases or emergencies

• 有競爭力的福利待遇**

• 帶薪公司假期， 帶薪休假、志願者時間 &更多！

• 學習 &發展機會

• Kenvuer Impact Networks

• 此列表可能因位置/地區而異

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