Pharmaceutical Process Engineer SME

TAI (Formerly TAI Engineering); Baltimore (MD); On-site; USD 120,000 - 155,000; Full time

Benefits offered by this job

Annual Profit Sharing Bonus

401(k) with employer match

Flexible work schedule

Professional Development

Tuition Reimbursement

Job summary

A leading engineering firm in Baltimore is seeking a Pharmaceutical Process Engineer SME. This role involves managing design and optimization projects for pharmaceutical clients, ensuring compliance with FDA regulations. Candidates should have a Chemical/Biochemical Engineering degree and 10+ years of experience in the field, with strong leadership and communication skills. This position offers competitive salary and benefits.

Qualifications

• Minimum 10 years of applicable experience with pharmaceutical manufacturing processes.
• Experience with FDA regulations and cGMP guidelines.
• Experience with Lean Manufacturing and Six Sigma methodologies.

Responsibilities

• Design and optimize pharmaceutical manufacturing processes.
• Ensure compliance with regulatory requirements and quality standards.
• Collaborate with R&D, quality assurance, and production teams.

Skills

Problem-solving

Analytical skills

Technical writing

Leadership skills

Interpersonal skills

Communication skills

Education

Bachelor's degree in Chemical Engineering, Biochemical Engineering, or related field

Tools

Microsoft Office (Outlook, Teams, Word, Excel, PowerPoint)

Bluebeam Revu

Job description

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.

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.

Day to Day Responsibilities

• 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.

Engineering Design (90‑95%)

• 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 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.

Business Development Support (5‑10%)

• 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.
• Act as liaison with corporate managers for process engineering scope and fee development.

Qualifications

• 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 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 manning estimates
• Manufacturing, process equipment, and process utility descriptions
• Process equipment sizing and specifications
• Process equipment datasheets
• Process utility requirements
• 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 Proficient With The Following Software

• Microsoft Office – Outlook, Teams, Word, Excel, and PowerPoint
• Engineering software and tools
• Bluebeam Revu

Compensation And Benefits

• Pay: $120,000–155,000 annually (based upon experience)
• Annual Profit Sharing Bonus (variable)
• PTO and Paid Holidays
• Health Benefits: Employee through family level coverage for medical, dental, and vision insurances. Company funded life and long‑term disability insurances. Short Term Disability, FSA, HSA, EAP, and supplemental life insurances (employee – family) are also available!
• 401(k) with employer match

Other Offerings

• The opportunity to make a real impact on a variety of industry‑leading projects.
• The ability to balance work and family activities.
• Flexible work schedule.
• Work in a dynamic and collaborative environment that values creativity and innovation.
• A chance to learn and grow alongside some of the brightest minds in engineering.
• Professional Development, Tuition Reimbursement, and Association Membership Reimbursements.

Discover what makes TAI a top‑20 manufacturing partner, according to Engineering News‑Record (ENR), and one of the top‑50 fastest‑growing private companies in the Baltimore Business Journal. Learn more about us at www.taiengineering.com.