Process Engineering Senior
Homeland Talent Solutions
Homeland Talent Solutions is partnering with a leading pharmaceutical manufacturing organization to identify a Senior Process Engineer to support continued growth, new product introductions, technology transfer initiatives, and manufacturing process improvement efforts within a highly regulated pharmaceutical environment.
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 Senior Process Engineer 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.
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
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
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
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
Lead technical projects and cross-functional initiatives
Serve as a subject matter expert for assigned manufacturing processes
Support the development and implementation of site procedures, technical standards, and best practices
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
- Statistical analysis experience, preferred
- Lean Manufacturing and Continuous Improvement experience, preferred
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$130.28k - $208.4k
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