Pharmaceutical Process Engineer SME

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.

About TAI

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 U.S., TAI offers single‑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 for both clients and each other.

• ◆Plan, organize, research, and perform preliminary and detailed design, preparing and reviewing documentation.
• ◆Receive general administrative direction from the division manager and design one or more projects of varying size and complexity.
• ◆Coordinate project documentation and direct CAD designers for the preparation of design drawings; interpret applicable regulations and standards; provide SME support for regulatory audits and inspections.
• ◆Coordinate project design with other engineering disciplines.

and quality standards.

• ✓Conduct risk assessments and process validation.
• ✓Implement process automation and control systems.
• ✓Perform troubleshooting and resolve process‑related issues.
• ✓Collaborate with R&D, quality assurance, and production teams.
• ✓Manage scale‑up processes from laboratory to production scale.
• ✓Document all processes and maintain detailed records utilizing good documentation practices (GDP).
• ✓Analyze process data and drive continuous improvement initiatives.
• ✓Provide subject‑matter expertise for teams and projects.
• ✓Perform process engineering design, including researching regulations and standards, preparing engineering calculations, studies, and detailed design documents.
• ✓Manage scope of work, budget, and schedule for tasks performed.
• ✓Direct CAD designers for the preparation of design drawings.
• ✓Perform design quality control and collaborate with multidisciplinary teams.
• ✓Ensure compliance with corporate standards for safety, quality control, and project management.
• ✓Ensure compliance with corporate process engineering and design standards.

• ✓Bachelor's degree in Chemical Engineering, Biochemical Engineering, or a related field.
• ✓Minimum 10 years of applicable experience with pharmaceutical manufacturing processes, 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 management.
• ✓Strong technical writing skills for documenting and reporting.
• ✓Strong problem‑solving and analytical skills.
• ✓Demonstrated leadership, interpersonal, and communication skills.
• ✓Ability to perform field work that includes walking, kneeling, sitting, standing, climbing stairs and/or ladders.
• ✓Willingness to travel to client sites.
• ✓Ability to interact with customers to gather critical information.
• ✓Ability to manage multiple projects and deadlines.
• ✓Ability to promote a team environment.
• ✓Excellent verbal and written communication skills; good customer relations; positive work attitude; willingness to learn new skills.

Proficiency In Development Of The Following Pharmaceutical Design Documentation

• ✓User Requirement Specifications (URS)
• ✓Process analytical and controls strategy
• ✓Product capacity verification calculations
• ✓Raw material and finished goods format

• ✓Quality control, in‑process testing, and Lab strategy
• ✓Product containment limits
• ✓Production and technical transfer details
• ✓Media, Energy, and Mass balances
• ✓Materials handling strategy
• ✓Value stream mapping
• ✓Batch documentation strategy
• ✓Equipment campaign, turnaround, and cleaning strategy
• ✓Operational manning estimates
• ✓Manufacturing, process equipment, and process utility descriptions
• ✓Process equipment sizing and specifications
• ✓Process equipment datasheets
• ✓Process utility

• ✓Standard Operating Procedures (SOP), work instructions, operator training guides, and preventative maintenance instructions
• ✓SME support for commissioning and qualification of equipment, utility systems and facilities, including IQ, OQ, and PQ
• ✓Process functional specifications
• ✓Process Block Diagrams (PBD)
• ✓Process Flow Diagrams (PFD)
• ✓Process and Instrumentation Diagrams (P&ID)

Candidates Shall Be Profi