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

• 競争力のある福利厚生パッケージ*

• 有給の会社の休日、 有給休暇、ボランティアタイム&詳細!

• 学習&開発の機会

• Kenvuer Impact Networks

• このリストは場所/地域によって異なる場合があります

*注:Kenvueの合計報酬には、給与、ボーナス(該当する場合)、および福利厚生が含まれます。あなたのタレントアクセスパートナーは、採用および採用中に、関連する場所の報酬提供総額と特定の給与範囲について詳しく共有することができます。採用プロセス.