Process Engineer III

The Process Engineer III serves as a technical program lead responsible for driving technology transfer, process design, and scale-up execution for multiple client manufacturing programs. This role acts as a primary technical interface for client programs and provides technical guidance to supporting team members and instruction on site-driven projects.

Essential Duties and Responsibilities

NPI Duties & Responsibilities

• Act as the designated functional SME for all assigned NPI and technology transfer projects.
• Participate in cross-functional Tech Transfer teams from project initiation through commercial launch.
• Lead discipline-specific assessments, gap analyses, risk evaluations, and readiness reviews.
• Support development and execution of project plans, timelines, and deliverables required for Tech Transfer stage gates.
• Provide technical expertise during customer meetings, technical discussions, audits, and governance reviews.
• Partner with Program Managers to identify project risks, mitigation plans, and escalation pathways.
• Ensure functional deliverables, documentation, and approvals are completed in accordance with established procedures and project timelines.
• Drive operational readiness activities necessary to support development, validation, and commercial manufacturing.
• Support knowledge transfer activities between sending and receiving organizations.
• Participate in Technical Review Boards (TRBs), stage gate reviews, and leadership governance meetings.
• Collaborate with cross-functional departments to resolve technical challenges and remove execution barriers.
• Contribute to continuous improvement of NPI and Tech Transfer processes, tools, templates, and best practices.

Tech Transfer & Program Leadership

• Lead technology transfer and scale-up activities for client formulation, sterile filtration, aseptic filling, and inspection/packaging operations.
• Generate and review batch records, engineering protocols, and process flow maps.
• Serve as the primary technical contact for routine client interactions, managing project timelines and presenting technical deliverables independently.
• Direct technical discussions and investigations, summarizing engineering-related work completed as written.
• Independently maintain project timelines and engineering deliverables, lead technical discussions, and present project status updates.

Process & Equipment Design

• Develop new procedures to meet facility and client requirements. Adhere to safety requirements at all times.
• Specify and qualify process-specific equipment (e.g., single-use systems, mixing vessels, homogenizers and filtration setups) based on facility and program requirements.
• Author standard operating procedures, work instructions, and other applicable process documentation.

Quality & Compliance Ownership

• Act as a Subject Matter Expert for cGMP quality events, leading deviations, root-cause investigations, CAPAs, and Change Control Requests from initiation through closure.

Floor Support & Training

• Provide technical oversight during critical engineering and cGMP batch runs, providing guidance and task-level direction to supporting engineering staff.
• Design and deliver technical training on general and client specific manufacturing processes and facility workflows to cross-functional teams.

Technical Mentorship

• Provide guidance, technical instruction, and project direction to junior engineers and supporting technical staff.

Education and Experience

• Bachelor’s degree in chemical engineering, Bioengineering, or related scientific/engineering discipline.
• Minimum of five (5) years’ experience as an engineer in a cGMP/FDA-regulated environment.
• Hands-on experience with aseptic fill/finish operations, cleanroom personnel and material flows, and process design.
• Strong working knowledge of aseptic processing technologies, including single-use strategies, sterile filtration, Pre-Use Post-Sterilization Integrity Testing (PUPSIT), CIP/SIP, container closure systems, and lyophilization.

Other Skills and Abilities

• Provides guidance and mentorship to team members
• Fosters a collaborative and positive work environment
• Champions change
• Promotes a safe and healthy work environment
• Demonstrates strong attention to detail and technical writing competency.
• Able to work independently to balance completing multiple tasks and drive projects to completion.
• Excellent communication skills. Meticulous and organized.
• Working knowledge of process engineering processing aids such as sanitary connections, valves, powder containment and pharmaceutical process design.