Process Engineer 5-Oral Solid Dosage

Job Description

The Sr. Lead Engineer is responsible for providing oversight for the discipline at a project, office and regional level. The Sr. Lead Engineer is responsible for managing the project discipline budgets on complex projects of all sizes or across a series of smaller projects. The Sr. Lead Engineer is responsible for directing and managing the workflows and execution of design and engineering support staff to meet client expectations and project goals.  

The Subject Matter Expert possesses rare and exceptional technical knowledge within their chosen specialization, coupled with general industry knowledge and experience. This broad and deep knowledge provides value to clients during project sponsorship and inception to ensure that the investment supports the business goals and accounts for constraints and external risks. This individual provides guidance for developing Lead and Senior Engineers to help identify and manage technical risks during execution and delivery.  

In addition, this role provides subject matter leadership in Oral Solid Dosage (OSD) facility and process design, including formulation, blending, granulation, compression, coating, and packaging operations. The Sr. Lead Engineer acts as both an internal and external OSD technical leader, advising on regulatory strategy, technology transfer, and commercialization readiness, and partnering with clients and project teams to ensure OSD solutions align with cGMP and regulatory requirements (FDA, EMA). 

This hybrid role can be based near any CRB office location

Core Activities 

• Provides industry-level perspective and guidance to frame business strategy in the face of evolving technology or client buying behavior.  

• Provides oversight and technical leadership across offices and related functions such as Business Development, Technical Advancement and Vertical Markets. 

• Leverages expertise to provide leadership to industry by participating in organizations, authoring technical papers or presenting in external venues. 

• Leads early-stage master planning, phasing strategy and design programming for highly complex or large-scale projects to support a client’s commercialization or tech transfer strategy. 

• Maintains active internal mentoring and external network of clients, peers and partners with strong relationships 

• Manages technical risks on strategic projects by conducting quality review of critical facility design features for regulatory and building code compliance. 

• Supports client engagement by maintaining key technical relationships with external peers, participation in strategic pursuits and supporting external marketing. 

• Directs and manages the workflows, design schedule and work plan to execute the design and engineering support staff to meet client expectations and project goals. 

OSD Specific Activities 

• Leads strategic OSD-focused projects, providing expertise on process design, scale-up, and integration of new technologies. 

• Mentors internal staff in OSD technologies and execution strategies, ensuring the development of future leaders within the discipline. 

• Builds and maintains a strong external presence in OSD industry forums (ISPE, PDA, AAPS), contributing through publications, technical committees, and speaking engagements. 

• Supports Business Development by expanding CRB’s OSD market presence and representing the firm as a recognized thought leader. 

Qualifications

Minimum Qualifications  

• ABET-accredited Bachelor’s in degree in chemical / biological / mechanical engineering 

• Master’s degree in an appropriate specialization 

• Minimum of 15 years of experience for Senior Lead position  

• Minimum of 20 years of experience for Senior or SME position  

• A mixture of design firm, operating company or construction related experience (within the market sector) 

• Demonstrated experience leading cross-functional teams in the design and delivery of OSD projects, including direct client engagement. 

Preferred Qualifications 

• Professional Engineering Licensure 

• A PhD in an appropriate specialization is desirable  

• Inspirational leader with excellent written and verbal communication skills 

• Extensive internal and external technical network including clients, vendors, peers and construction trade partners 

• Experience successfully leading large or complex projects from a technical perspective 

• Diverse experience across a variety of equipment and systems used in the life sciences or food and beverage industry 

• Ability to plan and direct work and manage time and productivity across multiple responsibilities 

• Recognized as an industry leader in OSD, with contributions such as technical publications, conference presentations, or standards development. 

• Experience with advanced OSD technologies (e.g., continuous manufacturing, PAT, high-potency containment).