TAI (Formerly TAI Engineering)
Pharmaceutical Process Engineer SME
TAI (Formerly TAI Engineering), Fairfax, Virginia, United States, 22032
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 will manage projects from concept through detailed design, performing tasks such as equipment sizing, process validation, and implementing control systems.
If you have a Chemical or Biochemical Engineering degree, deep knowledge of regulatory requirements, and are ready to contribute to operational excellence and business growth, we invite you to apply.
Overview of Responsibilities
Plan, organize, research, and perform preliminary and detailed design, preparing and reviewing documentation.
Coordinate project documentation and direct CAD designers for the preparation of design drawings.
Interpret applicable regulations and standards, and 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 utilities.
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, QA, and production teams.
Manage scale‑up processes from laboratory to production scale.
Document all processes and maintain detailed records using good documentation practices (GDP).
Analyze process data and drive continuous improvement initiatives.
Provide subject‑matter expertise for teams and projects.
Perform engineering calculations, studies, analyses, and prepare preliminary and detailed design documents.
Manage scope of work, budget, and schedule for tasks performed.
Direct CAD designers for the preparation of design drawings and perform design quality control.
Collaborate with multidisciplinary teams and 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 on proposals, client engagements, and discussions on TAI’s process engineering expertise.
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.
You’ll Be a Perfect Fit If You Have
Bachelor’s degree 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.
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, problem‑solving, analytical, 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 manage multiple projects and deadlines, promote a team environment, and interact with customers.
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 (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 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).
401(k) with employer match.
Other Offerings
The opportunity to make a real impact on a variety of industry‑leading projects.
Ability to balance work and family activities.
Flexible work schedule.
Work in a dynamic, collaborative environment that values creativity and innovation.
Chance to learn and grow alongside some of the brightest minds in engineering.
Professional development, tuition reimbursement, and association membership reimbursements.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Management and Manufacturing / Construction
Location and Salary Options
District of Columbia, United States – $122,000–$135,000
Indian Head, MD – $100,000–$130,000
Washington DC‑Baltimore Area – $120,000–$155,000
Fairfax, VA – $120,000–$155,000
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If you have a Chemical or Biochemical Engineering degree, deep knowledge of regulatory requirements, and are ready to contribute to operational excellence and business growth, we invite you to apply.
Overview of Responsibilities
Plan, organize, research, and perform preliminary and detailed design, preparing and reviewing documentation.
Coordinate project documentation and direct CAD designers for the preparation of design drawings.
Interpret applicable regulations and standards, and 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 utilities.
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, QA, and production teams.
Manage scale‑up processes from laboratory to production scale.
Document all processes and maintain detailed records using good documentation practices (GDP).
Analyze process data and drive continuous improvement initiatives.
Provide subject‑matter expertise for teams and projects.
Perform engineering calculations, studies, analyses, and prepare preliminary and detailed design documents.
Manage scope of work, budget, and schedule for tasks performed.
Direct CAD designers for the preparation of design drawings and perform design quality control.
Collaborate with multidisciplinary teams and 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 on proposals, client engagements, and discussions on TAI’s process engineering expertise.
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.
You’ll Be a Perfect Fit If You Have
Bachelor’s degree 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.
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, problem‑solving, analytical, 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 manage multiple projects and deadlines, promote a team environment, and interact with customers.
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 (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 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).
401(k) with employer match.
Other Offerings
The opportunity to make a real impact on a variety of industry‑leading projects.
Ability to balance work and family activities.
Flexible work schedule.
Work in a dynamic, collaborative environment that values creativity and innovation.
Chance to learn and grow alongside some of the brightest minds in engineering.
Professional development, tuition reimbursement, and association membership reimbursements.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Management and Manufacturing / Construction
Location and Salary Options
District of Columbia, United States – $122,000–$135,000
Indian Head, MD – $100,000–$130,000
Washington DC‑Baltimore Area – $120,000–$155,000
Fairfax, VA – $120,000–$155,000
#J-18808-Ljbffr