Senior Engineering Scientist

The Senior Engineering Scientist, Equipment is responsible for providing advanced technical leadership in the planning, development, implementation, qualification, and lifecycle management of manufacturing, packaging, and utility equipment. This role combines engineering innovation, scientific problem-solving, and project leadership to ensure equipment reliability, operational excellence, regulatory compliance, and successful business outcomes.

You will lead complex engineering initiatives, drive the adoption of emerging technologies, and partner cross-functionally with Manufacturing, MS&T, Quality, Automation, Packaging, Utilities, and external stakeholders to deliver innovative and scalable solutions that support business growth, quality, and customer requirements.

Key Responsibilities:

Technical Leadership & Innovation

• Lead the development and execution of advanced engineering projects, equipment strategies, and lifecycle management initiatives that support operational and business objectives.

• Conduct technical research, feasibility assessments, and engineering investigations to identify innovative solutions and continuous improvement opportunities.

• Evaluate, design, prototype, implement, and validate equipment, systems, and technical solutions that improve reliability, efficiency, compliance, and performance.

• Drive the integration of new technologies, automation solutions, and industry best practices into existing manufacturing and packaging operations.

• Analyze complex technical challenges involving multiple variables and develop sustainable solutions using data-driven decision-making methodologies.

Equipment & Asset Management

• Lead equipment installation, commissioning, qualification, validation, startup, and ongoing performance optimization activities.

• Develop and execute strategies that maintain high levels of equipment reliability, asset utilization, and Overall Equipment Effectiveness (OEE).

• Support equipment lifecycle management initiatives and identify opportunities to enhance performance while reducing operational risk and waste.

• Provide technical expertise in troubleshooting manufacturing, packaging, utilities, and equipment systems using structured problem-solving methodologies such as DMAIC, Root Cause Analysis, and Kepner-Tregoe.

• Ensure equipment remains in a qualified and compliant state throughout its lifecycle.

Project Management

• Lead multiple engineering and capital projects simultaneously, ensuring delivery of scope, schedule, budget, quality, and compliance objectives.

• Develop project plans, risk mitigation strategies, resource requirements, and execution roadmaps.

• Manage capital investment proposals, project spending, and budget tracking for assigned initiatives.

• Utilize project management tools and methodologies to drive execution, stakeholder alignment, and successful project outcomes.

• Provide input to long-range financial planning and strategic investment decisions.

Validation, Compliance & Quality

• Lead and support equipment qualification, computer system validation, commissioning, process validation, and packaging validation activities.

• Develop, review, approve, and maintain technical documentation including protocols, reports, risk assessments, engineering studies, SOPs, change controls, CAPAs, and technical memoranda.

• Ensure compliance with applicable GMP regulations, quality systems, regulatory requirements, and internal standards.

• Participate in investigations, non-conformance assessments, corrective and preventive actions, periodic reviews, and continuous quality improvement initiatives.

• Support inspection readiness and maintain compliance with applicable quality and regulatory frameworks.

Cross-Functional Collaboration

• Partner with Manufacturing, Quality, Automation, R&D, Packaging Development, Utilities, Supply Chain, and external vendors to deliver strategic business objectives.

• Translate scientific and engineering discoveries into practical, scalable manufacturing and operational solutions.

• Benchmark equipment technologies, processes, and best practices across sites to drive standardization and operational excellence.

• Effectively influence stakeholders and lead cross-functional teams without direct authority.

Talent Development & Mentorship

• Provide technical leadership, coaching, and mentorship to engineers and junior technical professionals.

• Foster a culture of innovation, continuous learning, knowledge sharing, and professional development.

• Guide project teams through technical decision-making and engineering problem-solving activities.

Safety, Health & Environment

• Promote and maintain a strong culture of Environmental Health & Safety (EHS), quality, and compliance.

• Ensure adherence to all applicable safety procedures, environmental regulations, and company policies.

• Support risk assessments and proactively identify opportunities to improve workplace safety and environmental performance.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, Industrial Engineering, Applied Science, or a related technical field.

• Minimum 4-6 years of progressive experience in engineering, manufacturing science, process engineering, equipment engineering, or related technical environments.

• Experience managing equipment qualification, commissioning, validation, troubleshooting, and lifecycle management activities.

• Strong understanding of manufacturing systems, engineering processes, and equipment reliability principles.

• Experience conducting technical investigations, root cause analysis, and implementing corrective actions.

• Knowledge of quality systems, GMP environments, regulatory requirements, and engineering compliance practices.

• Strong communication, collaboration, and project leadership skills.

• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.

Preferred Qualifications

• Advanced degree in Engineering, Applied Sciences, or related discipline.

• Experience in pharmaceutical, medical device, consumer healthcare, biotechnology, or highly regulated manufacturing environments.

• Knowledge of Computer System Validation (CSV), automation systems, and digital manufacturing technologies.

• Experience with advanced data analytics, simulation tools, statistical process control, and equipment performance monitoring.

• Demonstrated success leading capital projects and cross-functional initiatives.

• Knowledge of manufacturing and packaging equipment technologies.

• Bilingual English/Spanish proficiency.

Leadership Competencies

• Ability to lead complex projects independently and influence decision-making across multiple functions.

• Strong analytical and strategic thinking skills.

• Entrepreneurial mindset focused on innovation and continuous improvement.

• Exceptional stakeholder management, presentation, and communication abilities.

• Proven ability to balance technical excellence with business priorities and operational needs.

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