Job Details

About the Role

We are seeking a highly skilled Senior Engineer, Equipment to serve as the technical lead for process equipment supporting Bulk Drug Substance (BDS), Drug Product (DP), and Process Science (PS) systems. This role plays a critical part in ensuring equipment reliability, supporting manufacturing operations, and leading engineering projects from concept through implementation.

You will act as a subject matter expert for complex process systems, drive troubleshooting efforts, and lead capital and continuous improvement initiatives in a GMP-regulated environment.

Key Responsibilities

Technical Leadership

• Serve as the engineering technical lead for process systems including:
• Bioreactors, centrifuges, chromatography skids/columns
• Prep and hold tanks, CIP/SIP systems
• Filling and packaging equipment
• Troubleshoot equipment and process issues from qualification through system release
• Perform technical analysis including capacity planning, equipment utilization, and technology assessments
• Support sustainable design, value engineering, and implementation of new technologies

Project Management

• Lead and support CAPEX, OPEX, and continuous improvement (CI) projects
• Develop and review project execution plans and resource estimates
• Own risk assessments for new and existing systems
• Manage commissioning and startup activities, including:
• Approval of commissioning reports and protocols
• SOP development and review
• Provide technical oversight of contractors and project teams

Optimization & Compliance

• Drive continuous improvement and optimization of equipment performance
• Ensure compliance with GMP, quality, and EHS standards
• Lead or support deviation investigations, CAPA, change control, and risk assessments
• Act as System Owner when required (e.g., deviations, out-of-tolerance events)

Global Engineering & Best Practices

• Contribute to the development and implementation of engineering standards and best practices
• Participate in cross-functional and peer reviews
• Collaborate with global engineering teams to standardize processes and documentation

Qualifications

Required Experience & Skills

• Minimum 5+ years of hands-on experience with process equipment/systems
• At least 4+ years in a GMP manufacturing environment
• Strong expertise in troubleshooting complex technical issues
• Proven experience leading:
• Risk assessments
• Root cause investigations
• Equipment commissioning and qualification
• Experience managing change control, deviations, and CAPA processes
• Demonstrated project leadership (CAPEX or continuous improvement initiatives)
• Ability to manage contractors and cross-functional stakeholders
• Excellent written and verbal communication skills

Education

• Bachelor's degree in Engineering with 5–10 years of relevant experience, OR
• Master's degree in Engineering with 5+ years of experience, OR
• Professional Engineer (P.E.) license

Work Environment & Additional Requirements

• Primarily office-based with regular presence on the manufacturing floor
• Ability to work in a regulated (GMP) environment
• Occasional domestic and international travel may be required
• Must be able to meet standard visual and physical job requirements

What You'll Bring

• Strong ability to manage competing priorities in a fast-paced environment
• Collaborative mindset with experience working across functions (Manufacturing, Quality, Supply Chain, IT, etc.)
• Commitment to safety, compliance, and operational excellence