TAI (Formerly TAI Engineering)
Pharmaceutical Process Engineer SME
TAI (Formerly TAI Engineering), Rockville, Virginia, United States, 23146
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 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.
Here’s a Glimpse Into Your Day To Day
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.
Engineering Design (90-95%)
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.
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.
Liaise with corporate managers for process engineering scope and fee development.
You’ll Be a Perfect Fit If You Have
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 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 will include 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 relation skills, a positive work attitude, and 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 your 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.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Management and Manufacturing
Industries
Construction
#J-18808-Ljbffr
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 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.
Here’s a Glimpse Into Your Day To Day
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.
Engineering Design (90-95%)
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.
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.
Liaise with corporate managers for process engineering scope and fee development.
You’ll Be a Perfect Fit If You Have
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 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 will include 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 relation skills, a positive work attitude, and 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 your 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.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Management and Manufacturing
Industries
Construction
#J-18808-Ljbffr