Senior Process Engineer

About the role

This Senior Process Engineer role offers the opportunity to lead complex technical projects, support product commercialization efforts, and drive continuous improvement across manufacturing operations. Working closely with Manufacturing, Quality, Validation, Regulatory Affairs, Technical Services, and Executive Leadership, the Senior Process Engineer will serve as a key technical resource responsible for ensuring manufacturing processes remain efficient, compliant, scalable, and capable of consistently delivering high-quality products. This highly visible position provides significant project ownership, cross-functional collaboration, and the opportunity to directly influence manufacturing strategy, operational excellence, and future product introductions while supporting therapies used by patients worldwide.

Responsibilities

• Process Engineering & Manufacturing Support: Design, optimize, and improve pharmaceutical manufacturing processes; evaluate manufacturing workflows and identify opportunities to improve efficiency, quality, and reliability; establish and monitor process performance metrics to support operational excellence initiatives; provide technical troubleshooting and manufacturing support; drive continuous improvement activities focused on process robustness and product quality
• Technology Transfer & Product Lifecycle Management: Lead technology transfer activities for new products from internal and external partners; evaluate manufacturing processes for scalability, efficiency, robustness, and operational fit; support product ownership activities from initial evaluation through commercial manufacturing and lifecycle management; collaborate with cross-functional teams to ensure successful product transfers into manufacturing operations
• Validation & Technical Compliance: Author and execute validation protocols, studies, and supporting documentation; develop and support process validation strategies to ensure manufacturing consistency and product quality; analyze manufacturing data and process performance trends; support process qualification activities and regulatory compliance initiatives; participate in client audits, regulatory inspections, and technical reviews
• Quality & Continuous Improvement: Support deviation investigations and root cause analysis activities; develop and implement corrective and preventive actions (CAPAs); review process data and identify opportunities for quality improvement; partner with Manufacturing and Quality teams to drive operational excellence initiatives; support efforts to reduce deviations, improve yields, and optimize process performance
• Leadership & Technical Influence: Lead technical projects and cross-functional initiatives; provide guidance and mentorship to engineers and technical team members; serve as a subject matter expert for assigned manufacturing processes; support the development and implementation of site procedures, technical standards, and best practices

Requirements

• Bachelor's degree in Engineering, Chemistry, Biology, Physics, Pharmaceutical Sciences, or a related scientific discipline
• 5+ years of pharmaceutical manufacturing or FDA-regulated industry experience
• Experience supporting process engineering, manufacturing, validation, or technology transfer activities
• Strong project management and cross-functional leadership skills
• Experience troubleshooting manufacturing processes and driving process improvements
• Strong communication, presentation, and technical writing abilities
• Prior leadership, mentoring, or project leadership experience

Qualifications

• Master's degree, preferred
• Sterile injectable manufacturing experience, preferred
• Aseptic processing experience, preferred
• Process validation expertise, preferred
• Statistical analysis experience, preferred
• Lean Manufacturing and Continuous Improvement experience, preferred
• Technology transfer experience, preferred
• Pharmaceutical CDMO experience, preferred

Benefits

• Competitive annual salary of $98,700–$157,900
• Comprehensive medical, dental, and vision coverage (benefits begin on day one)
• HSA and FSA options
• Life and AD&D insurance
• Short- and long-term disability coverage
• Employee Assistance Program
• Ongoing career development opportunities
• Annual compensation reviews and clear paths for professional growth and advancement