Director, Engineering

Job Description

We are seeking a highly skilled and strategic Reliability Engineering Director to lead our reliability engineering efforts within the Vaccine manufacturing environment. This role is critical to ensuring the continuous, compliant, and efficient operation of manufacturing equipment and systems that support drug production. The ideal candidate will combine deep technical expertise in reliability engineering with strong leadership capabilities and a thorough understanding of pharmaceutical industry regulations and quality standards.

• Lead and develop the reliability engineering team composed of engineers focused on vaccine manufacturing equipment and systems.
• Develop and implement reliability strategies to maximize equipment uptime, reduce unplanned downtime, and extend asset life while ensuring compliance with FDA, EMA, and other regulatory requirements.
• Collaborate closely with Quality Assurance, Validation, Manufacturing, Maintenance, and Engineering teams to embed reliability best practices into equipment design, maintenance, qualification, and operation.
• Facilitate RBAM (reliability based asset management) on key manufacturing assets and utilize/track key reliability metrics such as MTBF (Mean Time Between Failures), MTTR (Mean Time To Repair), and OEE (Overall Equipment Effectiveness) ensuring actions are completed and driving improved performance and risk ranking of assets.
• Drive root cause analysis and failure investigations for critical equipment, ensuring corrective and preventive actions (CAPA) are implemented effectively.
• Oversee reliability-centered maintenance (RCM) programs and predictive maintenance initiatives using condition monitoring and data analytics.
• Ensure all reliability activities comply with Good Manufacturing Practices (GMP) and support audit readiness.
• Lead risk assessments related to equipment reliability and support validation activities, including IQ/OQ/PQ protocols.
• Manage budgets, resources, and timelines for reliability projects and continuous improvement initiatives.
• Communicate reliability goals, progress, and outcomes to senior leadership and cross-functional stakeholders.

• Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related technical field)
• Master’s degree preferred.

• 10+ years of experience in reliability engineering or maintenance engineering within pharmaceutical manufacturing or a highly regulated industry.
• Minimum 5 years in a leadership role managing reliability or maintenance teams.
• Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements (FDA, EMA, GMP).
• Expertise in reliability engineering tools and methodologies such as FMEA, RCM, Weibull analysis, fault tree analysis, and root cause analysis.
• Experience with Enterprise Asset Management systems (EAM) and reliability data analytics tools.
• Proven ability to lead cross-functional teams and influence at all organizational levels.
• Excellent problem-solving, communication, and project management skills.

• Experience with pharmaceutical equipment qualification and validation processes.
• Certifications such as Certified Reliability Engineer (CMRP), Six Sigma, or Lean Manufacturing.
• Familiarity with risk management frameworks (e.g., ICH Q9).
• Knowledge of automation and control systems used in pharmaceutical manufacturing.

• Competitive salary and comprehensive benefits package.
• Opportunity to lead reliability initiatives critical to patient safety and product quality.
• Dynamic and collaborative work environment within a leading pharmaceutical company.
• Professional development and career advancement opportunities.

Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a hybrid work consisting of three total days on‑site per week, Monday‑Thursday, although the specific days may vary by site or organization, with Friday designated as a remote‑working day, unless business critical tasks require an on‑site presence. This hybrid work model does not apply to, and daily in‑person attendance…