Pharmaceutical Process Engineer SME

TAI (Formerly TAI Engineering); Rockville (VA); 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 opportunities

Job summary

A leading engineering firm is looking for a Pharmaceutical Process Engineer SME based in Rockville, Virginia. In this role, you will be responsible for driving engineering design and optimization projects for pharmaceutical clients. The ideal candidate will have a Chemical Engineering degree and at least 10 years of experience in pharmaceutical manufacturing, with strong project management and regulatory knowledge. This position offers a salary range of $120,000–155,000 and a comprehensive benefits package.

Qualifications

• Minimum 10 years of experience with pharmaceutical manufacturing processes.
• Deep understanding of 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

Project management

Technical writing

Problem-solving

Analytical skills

Customer relations

Education

Bachelor’s degree in Chemical Engineering or related field

Tools

Microsoft Office

Engineering software

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 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