Job Description

The Senior Engineer is responsible for providing technical leadership in support of manufacturing equipment, process optimization, reliability engineering, and capital projects within a regulated manufacturing environment. This role independently develops engineering solutions to improve equipment performance, reliability, and operational efficiency while ensuring compliance with quality, safety, and regulatory requirements. The Senior Engineer serves as a Subject Matter Expert (SME) for assigned manufacturing systems, providing technical guidance, leading equipment improvement initiatives, and collaborating with cross-functional teams to support manufacturing operations.

Key Responsibilities

• Lead process optimization and troubleshooting activities for manufacturing equipment and operations.
• Develop and implement engineering solutions for complex technical and operational challenges.
• Design and support system modifications, equipment upgrades, and capital improvement projects.
• Develop engineering procedures, standards, and best practices.
• Provide technical leadership and mentorship to engineers, technicians, and project teams.
• Support manufacturing, process development, quality, facilities, and engineering initiatives.
• Serve as the equipment owner for assigned manufacturing systems.
• Manage equipment lifecycle activities within the Computerized Maintenance Management System (CMMS), including:
• Work order review, approval, and closure
• Preventive maintenance (PM) strategy development
• Spare parts identification and optimization
• Equipment documentation updates
• Collaborate with Maintenance and Engineering teams to establish effective maintenance strategies.
• Develop and monitor equipment performance metrics, including availability, reliability, downtime, and maintenance effectiveness.
• Identify opportunities to improve equipment reliability, reduce downtime, and optimize asset performance.
• Lead equipment reliability and continuous improvement initiatives.
• Perform equipment reliability assessments and support change control activities.
• Serve as the Subject Matter Expert (SME) for assigned manufacturing systems, providing technical guidance for design, maintenance, and compliance activities.
• Support equipment troubleshooting and technical investigations.
• Participate in equipment qualification, validation, and commissioning activities as required.
• Ensure engineering documentation complies with applicable quality and regulatory requirements.
• Support investigations involving equipment-related deviations and non-conformances.
• Develop, implement, and monitor Corrective and Preventive Actions (CAPA).
• Participate in root cause investigations and effectiveness reviews.
• Evaluate equipment changes and assess potential impacts on validated systems and manufacturing operations.
• Lead engineering and equipment improvement projects from planning through implementation.
• Coordinate project activities with contractors, consultants, equipment vendors, and internal stakeholders.
• Develop project schedules, budgets, technical documentation, and engineering deliverables.
• Ensure projects are completed safely, on schedule, within budget, and in compliance with quality standards.
• Promote Environmental, Health, and Safety (EHS) compliance throughout engineering activities.
• Partner with Manufacturing, Maintenance, Quality, Validation, Facilities, and Engineering teams to resolve technical issues and improve operational performance.
• Support internal audits, regulatory inspections, and continuous improvement initiatives.
• Perform additional duties as assigned.

Skills

• Strong understanding of engineering principles and manufacturing operations.
• Knowledge of GMP, GLP, and regulated manufacturing environments.
• Experience with equipment reliability, maintenance strategies, and continuous improvement methodologies.
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent technical writing, documentation, and communication skills.
• Ability to manage multiple projects and priorities simultaneously.
• Basic project management, scheduling, and budget management experience.
• Strong collaboration, leadership, and stakeholder management skills.
• Ability to coordinate contractors, vendors, and cross-functional teams.
• Commitment to Environmental, Health, and Safety (EHS) compliance and operational excellence.

Requirements

Qualifications

• Doctorate degree, OR
• Master's degree with 3+ years of Engineering experience, OR
• Bachelor's degree in Engineering with 5+ years of Engineering experience.

Preferred Qualifications

• Experience supporting biotechnology, pharmaceutical, medical device, or other regulated manufacturing environments.
• Experience serving as equipment owner within a Computerized Maintenance Management System (CMMS).
• Strong background in equipment reliability engineering and maintenance optimization.
• Experience with preventive maintenance strategies, spare parts management, and asset lifecycle management.
• Experience leading equipment improvement and reliability projects.
• Knowledge of change control, deviation investigations, CAPA, and risk assessments.
• Familiarity with equipment qualification, validation, and regulatory compliance in GMP environments.

Benefits

• 6-month contr4act with possible extension
• Administrative Shift