Pharmaceutical Process Engineer SME
TAI EngineeringRockville, MD, United States1 day ago
Job type
- Full-time
Job descriptionDesigning 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. 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. 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. 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) Microsoft Office - Outlook, Teams, Word, Excel, and PowerPoint Engineering software and tools. Bluebeam Revu 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 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.
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 like 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 have found that the best employees are the ones who recognize the importance of what they do and the ones who let that guide them in the actions they take. More than any skill, we seek people who make decisions that support the common good. We work for our clients, and we work for one another.
Here's a glimpse into your day to day :
- 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%) :
Business Development support (5-10%) :
You'll be a perfect fit if you have :
Proficiency in development of the following pharmaceutical design documentation :
Candidates shall be proficient with the following software :
Compensation and Benefits :
Other Offerings :
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.
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