Pharmaceutical Process Engineer SME

Join TAI (Formerly TAI Engineering) as a Pharmaceutical Process Engineer SME and lead critical engineering design and optimization projects for our pharmaceutical clients. You will manage projects from concept through detailed design, performing tasks such as equipment sizing, process validation, and implementing control systems.

You’ll be responsible for planning, organizing, researching, performing preliminary and detailed design, preparing and reviewing documentation, and coordinating project design with other engineering disciplines. You must have a Chemical/Biochemical Engineering degree and deep knowledge of regulatory requirements.

• Responsible for planning, organizing, researching, performing 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.

• Design and optimize pharmaceutical manufacturing processes, including sizing and selection of process equipment and utility systems.
• Ensure compliance with regulatory requirements 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 design documents.
• Manage scope of work, budget, and schedule for tasks performed.
• Direct CAD designers for design drawings.
• Perform design quality control.
• Collaborate with multidisciplinary teams.
• Ensure compliance with corporate and industry standards for safety, quality control, and project management.

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

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or a related field.
• Minimum 10 years of 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, quality control, pharmaceutical safety protocols, and risk management.
• Strong technical writing, problem‑solving, analytical, leadership, interpersonal, and communication skills.
• Ability to perform field work, including walking, kneeling, sitting, standing, climbing stairs or ladders.
• Willingness to travel to client sites.
• Ability to manage multiple projects and deadlines and promote a team environment.

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