TAI (Formerly TAI Engineering) · 1 day ago
Pharmaceutical Process Engineer SME
DC-Baltimore Area
Full-time
Hybrid
Senior Level, Lead/Staff
$120K/yr - $155K/yr
10+ years expTAI is a full-service, multi-disciplinary engineering and construction firm that partners with leading organizations in various sectors. They are seeking a Pharmaceutical Process Engineer SME to manage engineering design and optimization projects for pharmaceutical clients, focusing on equipment sizing, process validation, and compliance with regulatory standards.
Responsibilities
Individuals in this position are responsible for planning, organizing, researching, performing preliminary and detailed design, preparing and reviewing documentation
This position receives general administrative direction from the division manager and is 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, preparing studies and analyses, and preparing preliminary and detailed engineering design documents
Responsible for 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 standards for safety, quality control, and project management
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
Liaison with corporate managers for process engineering scope and fee development
Qualification
Required
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
Preferred
Proficiency in development of 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 Microsoft Office – Outlook, Teams, Word, Excel, and PowerPoint, Engineering software and tools, Bluebeam Revu
Benefits
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
Flexible work schedule
Professional Development, Tuition Reimbursement, and Association Membership Reimbursements
Company
TAI (Formerly TAI Engineering)
TAI (Formerly TAI Engineering) is a full-service, multi-disciplinary engineering and construction firm built to scale — delivering mission-critical, integrated solutions across the full design–build–maintain lifecycle.
201-500 employees
Funding
Current Stage
Growth StageRecent News
Company data provided by crunchbase