Pharmaceutical Process Engineer SME

About the Role

Join TAI as a Pharmaceutical Process Engineer SME to drive critical engineering design and optimization projects for our pharmaceutical clients. In this key role, you'll manage projects from concept through detailed design, performing tasks such as equipment sizing, process validation, and implementing control systems. If you have a Chemical/Biochemical Engineering degree, deep knowledge of regulatory requirements, and are ready to contribute to both operational excellence and business growth, we invite you to apply.

TAI has been a leading multidisciplinary firm for over 35 years, providing expert engineering, management, and technical services to industrial, manufacturing, commercial, and mission critical markets. With over 300 skilled professionals, 16 different divisions, and 6 offices across the US, TAI offers sole‑source solutions for complex projects, built on long‑term client partnerships and a culture that attracts top talent. Team members at TAI are capable, well‑rounded, flexible, and optimistic.

We seek people who make decisions that support the common good and work both for clients and for one another.

• Plan, organize, research, perform preliminary and detailed design, prepare and review documentation.
• Receive general administrative direction from the division manager and be responsible for design of one or more projects of varying size and complexity.
• Coordinate project documentation and direct CAD designers for the preparation of design drawings. Possess ability to interpret applicable regulations and standards. Provide SME support for regulatory audits and inspections.
• Coordinate project design with other engineering disciplines.

• Designing and optimizing pharmaceutical manufacturing processes, including sizing and selection of process equipment and process utility systems.
• Ensuring compliance with regulatory requirements and quality standards.
• Conducting risk assessments and process validation.
• Implementing process automation and control systems.
• Performing troubleshooting and resolving process‑related issues.
• Collaborating with R&D, quality assurance, and production teams.
• Managing scale‑up processes from laboratory to production scale.
• Documenting all processes and maintaining detailed records utilizing good documentation practices (GDP).
• Analyzing process data and driving continuous improvement initiatives.
• Providing subject matter expertise for teams and projects.
• Performing process engineering design, including researching regulations and standards, preparing engineering calculations, studies, and preliminary and detailed engineering design documents.
• Managing scope of work, budget, and schedule for tasks performed.
• Directing CAD designers for the preparation of design drawings.
• Performing design quality control.
• Collaborating with multidisciplinary teams.
• Ensuring compliance with corporate safety, quality control, and project management standards.
• Ensuring compliance with corporate process engineering and design standards.

• Attend site walks and on‑site meetings as required.
• Collaborate with the business development team, contributing to proposals, client engagements, and discussions on TAI’s process engineering expertise and technical approach.
• Support relationships of existing clients to promote maintenance and growth of those relationships.
• Assist in proposal development and engineering fee estimation for opportunities identified by the business development team.
• Liaise with corporate managers for process engineering scope and fee development.

• Bachelor’s degree from an accredited university in Chemical Engineering, Biochemical Engineering, or a related field.
• Minimum 10 years of applicable experience with pharmaceutical manufacturing processes and equipment, FDA regulations, and cGMP guidelines.
• Applicable project experience with cross‑functional engineering teams.
• Experience with Lean Manufacturing and Six Sigma methodologies.
• Understanding of process validation and quality control.
• Understanding of pharmaceutical safety protocols and risk…