Principal Process Engineer
Listed on 2026-08-29
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Engineering
Regulatory Compliance Specialist, Quality Engineering, Process Engineer, Validation Engineer
Homeland Talent Solutions is partnering with a leading pharmaceutical manufacturing organization to identify a Principal Process Engineer to support continued growth, product expansion, technology transfer initiatives, and operational excellence efforts within a highly regulated manufacturing environment.
The Principal Process Engineer will serve as a site-wide technical authority responsible for supporting pharmaceutical manufacturing operations, technology transfer programs, process optimization initiatives, validation efforts, and client-facing technical discussions. Working closely with Manufacturing, Quality, Validation, Regulatory Affairs, Technical Services, and Executive Leadership, this individual will lead high-priority projects that directly impact product commercialization, manufacturing performance, and long-term business success.
This highly visible Principal Process Engineer position offers the opportunity to influence manufacturing strategy, lead complex technology transfer initiatives, mentor engineering talent, and serve as a trusted advisor to both internal leadership and external clients. The ideal candidate is a collaborative technical leader who enjoys solving complex challenges, driving continuous improvement, and making a meaningful impact on products used by patients worldwide.
Responsibilities- Serve as a site-wide subject matter expert in pharmaceutical process engineering
- Provide strategic leadership for manufacturing process design, optimization, and continuous improvement initiatives
- Evaluate manufacturing processes for scalability, robustness, efficiency, and regulatory compliance
- Drive technical problem-solving efforts supporting manufacturing operations
- Support long-term process ownership and product lifecycle management strategies
- Lead multiple concurrent technology transfer projects and assess incoming products for successful site implementation
- Support new product introductions and manufacturing scale-up initiatives
- Partner cross-functionally to ensure successful product transfers and commercialization efforts
- Author, review, and oversee validation protocols, reports, and supporting technical documentation
- Support process validation strategies and execution activities
- Lead investigations, deviations, change controls, and corrective action initiatives
- Ensure compliance with cGMP regulations and pharmaceutical manufacturing requirements
- Support regulatory inspections, audits, and client reviews
- Serve as the primary technical representative during client-facing meetings and technical discussions
- Present technical recommendations and support strategic decision-making initiatives
- Mentor and develop Process Engineers and Technical Services team members
- Provide technical guidance across multiple departments and support organizational initiatives as needed
- Serve as a delegate for Technical Services leadership during client meetings, project reviews, and operational discussions
- Bachelor's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical discipline
- 10+ years of pharmaceutical manufacturing, biopharmaceutical manufacturing, or FDA-regulated industry experience
- Expert-level process engineering and technology transfer experience
- Experience supporting manufacturing operations within regulated manufacturing environments
- Strong project leadership and cross-functional collaboration skills
- Excellent technical communication, presentation, and problem-solving abilities
- Prior leadership, mentoring, or supervisory experience
- Master's degree or PhD, preferred
- Aseptic processing experience, preferred
- Process validation expertise, preferred
- Statistical analysis and process capability experience, preferred
- Lean Manufacturing and Continuous Improvement experience, preferred
- CDMO or contract manufacturing experience, preferred
This role offers a competitive annual salary of $130,275–$208,400, along with a comprehensive benefits package. Benefits begin on day one and include medical, dental, and vision coverage, HSA and FSA options, life and AD&D insurance, short- and long-term disability coverage, and an Employee Assistance Program. Employees also benefit from…
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