Senior Engineering Manager

Role Responsibilities

• Develop, implement, and oversee a capital spend program, aligning with the company’s strategic objectives and budgetary constraints.
• Monitor capital expenditures and ensure efficient allocation of resources across multiple projects.
• Provide regular updates to senior management on capital spend, project status, and potential risks or opportunities.
• Lead the planning, design, and execution of high-impact capital projects, ensuring adherence to timelines, budgets, and quality standards.
• Collaborate with cross-functional teams, including manufacturing, quality, and regulatory, to ensure projects meet CGMP and ISO requirements.
• Manage project teams, including internal staff, contractors, and vendors, to deliver projects on time and within scope.
• Oversee the commissioning, qualification, and validation of new equipment and facilities, ensuring compliance with regulatory standards.
• Drive the implementation of automation technologies to improve manufacturing efficiency, reduce downtime, and enhance product quality.
• Evaluate and select automation solutions that align with the company’s manufacturing needs and regulatory requirements.
• Ensure seamless integration of automation systems with existing processes and infrastructure.
• Ensure regulatory compliance and quality assurance by developing and enforcing standard operating procedures (SOPs) and best practices for engineering activities.
• Support internal and external audits, providing documentation and addressing any findings related to engineering projects.

Team Leadership and Development

• Manage and mentor a team of engineers and technical staff, fostering a culture of continuous improvement and professional growth.
• Identify training needs and provide opportunities for staff to enhance their skills and knowledge in relevant areas.
• Promote a safety-first culture by ensuring all engineering activities adhere to safety regulations and protocols.

Basic Qualifications

• Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related field). Advanced degree preferred.
• 15+ years of experience in engineering roles, with a focus on capital projects in a pharmaceutical manufacturing environment.
• Proven experience in managing large-scale capital projects, including budgeting, scheduling, and resource allocation.
• Strong knowledge of CGMP regulations, FDA requirements, and ISO cleanroom guidelines.
• Background in automation technologies and their application in manufacturing processes.
• Excellent project management skills, including the ability to lead cross-functional teams and manage multiple projects simultaneously.
• Strong problem-solving, decision-making, and leadership abilities.
• Effective communication and interpersonal skills.

Preferred Skills

• Certification in Project Management (PMP) or related disciplines.
• Experience with pharmaceutical facility design and construction.
• Familiarity with lean manufacturing principles and continuous improvement methodologies.
• Proficiency with project management software.