Director, Engineering
Merck
2 hours ago
Remote friendly (West Point, PA)
United States
IT
Key Responsibilities:
- Lead and develop the reliability engineering team for vaccine manufacturing equipment and systems.
- Develop and implement reliability strategies to maximize equipment uptime, reduce unplanned downtime, extend asset life, and ensure compliance with FDA, EMA, and other regulatory requirements.
- Collaborate with Quality Assurance, Validation, Manufacturing, Maintenance, and Engineering to embed reliability best practices into equipment design, maintenance, qualification, and operation.
- Facilitate RBAM (reliability based asset management) on key manufacturing assets; use/track MTBF, MTTR, and OEE to ensure actions are completed, improve performance, and improve asset risk ranking.
- Drive root cause analysis and failure investigations for critical equipment; ensure CAPA is implemented effectively.
- Oversee reliability-centered maintenance (RCM) programs and predictive maintenance initiatives using condition monitoring and data analytics.
- Ensure 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.
Education Requirements:
- Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related technical field)
- Master’s degree preferred
Required Experience And Skills:
- 10+ years 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/methodologies: FMEA, RCM, Weibull analysis, fault tree analysis, root cause analysis.
- Experience with Enterprise Asset Management systems (EAM) and reliability data analytics tools.
- Ability to lead cross-functional teams and influence at all organizational levels.
- Excellent problem-solving, communication, and project management skills.
Preferred Experience And Skills:
- Experience with pharmaceutical equipment qualification and validation processes.
- Certifications such as 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.
What We Offer:
- Competitive salary and comprehensive benefits package.
- Opportunity to lead reliability initiatives critical to patient safety and product quality.
- Dynamic and collaborative work environment.
- Professional development and career advancement opportunities.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee).
- Application deadline: stated on the posting (Requisition ID: R394016).
- Lead and develop the reliability engineering team for vaccine manufacturing equipment and systems.
- Develop and implement reliability strategies to maximize equipment uptime, reduce unplanned downtime, extend asset life, and ensure compliance with FDA, EMA, and other regulatory requirements.
- Collaborate with Quality Assurance, Validation, Manufacturing, Maintenance, and Engineering to embed reliability best practices into equipment design, maintenance, qualification, and operation.
- Facilitate RBAM (reliability based asset management) on key manufacturing assets; use/track MTBF, MTTR, and OEE to ensure actions are completed, improve performance, and improve asset risk ranking.
- Drive root cause analysis and failure investigations for critical equipment; ensure CAPA is implemented effectively.
- Oversee reliability-centered maintenance (RCM) programs and predictive maintenance initiatives using condition monitoring and data analytics.
- Ensure 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.
Education Requirements:
- Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related technical field)
- Master’s degree preferred
Required Experience And Skills:
- 10+ years 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/methodologies: FMEA, RCM, Weibull analysis, fault tree analysis, root cause analysis.
- Experience with Enterprise Asset Management systems (EAM) and reliability data analytics tools.
- Ability to lead cross-functional teams and influence at all organizational levels.
- Excellent problem-solving, communication, and project management skills.
Preferred Experience And Skills:
- Experience with pharmaceutical equipment qualification and validation processes.
- Certifications such as 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.
What We Offer:
- Competitive salary and comprehensive benefits package.
- Opportunity to lead reliability initiatives critical to patient safety and product quality.
- Dynamic and collaborative work environment.
- Professional development and career advancement opportunities.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee).
- Application deadline: stated on the posting (Requisition ID: R394016).