Process Engineer III

Key Responsibilities:
- Ensure new equipment is appropriately designed, qualified, and maintained across the equipment lifecycle
- Own and manage equipment changes to maintain a validated and compliant state
- Investigate equipment and process deviations; implement corrective actions to prevent recurrence
- Serve as subject matter expert during audits and respond to regulatory observations
- Develop and implement compliant equipment reliability and maintenance strategies
- Lead or support capital projects with subject matter expertise and technical guidance
- Collaborate with operations for new product introductions and facility fit evaluations
- Establish equipment specifications (user requirements, functional, and design specifications)
- Evaluate and implement new technologies and equipment platforms for manufacturing operations
- Mentor process engineers and lead small teams to optimize engineering systems and processes

Essential Requirements:
- Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering (or related technical field)
- Minimum 5 years pharmaceutical or biopharmaceutical GMP manufacturing experience (or equivalent)
- Strong knowledge of FDA regulations and GMP systems
- Demonstrated experience supporting engineering activities in a regulated pharmaceutical/biotechnology environment
- Proven ability to lead cross-functional teams in a fast-paced environment
- Strong project management skills (strategic and long-term planning)
- Excellent written and verbal communication skills with technical writing capabilities
- Ability to analyze complex issues and implement effective, compliant engineering solutions

Compensation & Benefits (as stated):
- Expected salary range: $98,700–$183,300 annually
- Performance-based cash incentive; potential for annual equity awards (depending on level)
- Comprehensive benefits package (US-based eligible employees) and time off package