As an
Engineer III, Site Engineering & Facilities, you will be a key technical driver in the design, implementation, and lifecycle management of single-use manufacturing systems within our gene therapy production facility. This role serves as a vital cross-functional partner to Manufacturing, Process Sciences, Supply Chain, and Quality Assurance, ensuring that our viral vector production remains compliant, efficient, and innovative within a cGMP environment.
CoreResponsibilities:Engineering Standards & Automation
- Standard Development: Serve as a core member of the FUME team, contributing to the creation and application of site-wide engineering and automation standards.
- Capital Support: Provide technical support for site engineering and facility capital projects. Take ownership of small-scale projects, managing design, procurement, and implementation.
Equipment Lifecycle Management
- Technical Execution: Execute the full lifecycle of automation and equipment for internal groups, including specification, procurement, testing, onboarding, and qualification (IQ/OQ/PQ).
- Validation & Maintenance: Sustain the validated state of site equipment through robust preventative maintenance and calibration systems.
- Vendor Management: Manage vendor service and calibration contracts, review turnover packages, and coordinate on-site service schedules.
Manufacturing Operations & Compliance
- Manufacturing Support: Deliver real-time troubleshooting for active manufacturing campaigns. Coordinate repairs with external vendors to minimize downtime (includes on-call/weekend support as needed).
- Quality Documentation: Partner with QA to lead the lifecycle management of engineering documentation, including SOPs, Change Controls, and GEP (Good Engineering Practice) protocols.
- EHS & Regulatory: Maintain 100% compliance with internal EHS guidelines, site registrations, and cGMP/environmental regulations.
Training & Mentorship
- Skill Development: Act as a subject matter expert (SME) by providing technical training on new equipment and operational procedures to the wider site team.
Requirements- Education: Bachelor's degree in Engineering (Mechanical, Chemical, or Bioengineering preferred).
- Experience: 5-9 years of directly relevant experience in the biotech, pharmaceutical, or gene therapy space.
- Technical Knowledge: Proven expertise in facility, process, or manufacturing engineering. Single-use technology and viral vector manufacturing experience is highly preferred.
- Regulatory Fluency: Deep understanding of cGMP systems and FDA/EU regulations.
- Operational Flexibility: Ability to provide on-call or in-person support for batch processing operations.
- Soft Skills: Strong troubleshooting, organizational, and interpersonal skills. Must be a proactive team player.
- Travel: Ability to travel up to 10% for vendor visits or headquarters requirements.
Benefits- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave: (Maternity, Paternity)
- Short Term & Long Term Disability
- Training & Development
- Stocked micro-kitchen with drinks and snacks
- Wellness Resources
