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)
- 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:
- 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