Pharmaceutical Process Engineer SME

Description

• Individuals in this position are responsible for planning, organizing, researching, performing preliminary and detailed design, preparing and reviewing documentation.
• Ensuring compliance with regulatory requirements and quality standards.
• Assist in proposal development and engineering fee estimation for opportunities identified by the business development team.
• Collaborating with R&D, quality assurance, and production teams
• 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.
• Process equipment datasheets,
• Process Flow Diagrams (PFD),
• Responsible for managing scope of work, budget, and schedule for tasks performed.
• Documenting all processes and maintaining detailed records utilizing good documentation practices (GDP).
• Coordinate project design with other engineering disciplines.
• Attend site walks and on-site meetings as required.
• Performing design quality control.
• Collaborating with multidisciplinary teams.
• Process equipment sizing and specifications,
• Providing subject matter expertise for teams and projects.
• Analyzing process data and driving continuous improvement initiatives.
• Collaborate with the business development team, contributing to proposals, client engagements, and discussions on TAI’s process engineering expertise and technical approach.
• Managing scale-up processes from laboratory to production scale.
• Implementing process automation and control systems.
• Performing process engineering design, including researching regulations and standards, preparing engineering calculations, preparing studies and analyses, and preparing preliminary and detailed engineering design documents.
• Ensuring compliance with corporate standards for safety, quality control, and project management.
• SME support for commissioning and qualification of equipment, utility systems and facilities, including IQ, OQ, and PQ,
• Designing and optimizing pharmaceutical manufacturing processes, including sizing and selection of process equipment and process utility systems.
• Ensuring compliance with corporate process engineering and design standards.
• Liaison with corporate managers for process engineering scope and fee development.
• Performing troubleshooting and resolving process-related issues.
• Product capacity verification calculations,
• 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.
• Support relationships of existing clients to promote maintenance and growth of those relationships.
• Process Block Diagrams (PBD),
• Directing CAD designers for the preparation of design drawings.
• Conducting risk assessments and process validation.
• Engineering software and tools.

Requirements

• Ability to manage multiple projects and deadlines.
• Understanding of pharmaceutical safety protocols and risk management.
• Bluebeam Revu
• The ability to balance your work and family activities.
• Bachelor’s degree from an accredited university in Chemical Engineering, Biochemical Engineering, or a related field.
• Ability to promote a team environment.
• Strong technical writing skills for documenting and reporting.
• Minimum 10 years of applicable experience with pharmaceutical manufacturing processes and equipment, FDA regulations, and cGMP guidelines.
• Standard Operating Procedures (SOP), work instructions, operator training guides, and preventative maintenance instructions,
• Strong problem-solving and analytical skills.
• Demonstrated leadership, interpersonal, and communication skills.
• Ability to interact with customers to gather critical information.
• Applicable project experience with cross-functional engineering teams.
• Experience with Lean Manufacturing and Six Sigma methodologies.
• Willingness to travel to client sites.
• Process and Instrumentation Diagrams (P&ID)
• Excellent verbal and written communication skills, good customer relation skills, a positive work attitude, and willingness to learn new skills.
• Microsoft Office – Outlook, Teams, Word, Excel, and PowerPoint
• Ability to perform field work that will include walking, kneeling, sitting, standing, climbing stairs and/or ladders.
• Understanding of process validation and quality control.

Benefits

• Pay: $120,000-155,000 annually (based upon experience)
• A chance to learn and grow alongside some of the brightest minds in engineering.
• Work in a dynamic and collaborative environment that values creativity and innovation.
• PTO and Paid Holidays
• Professional Development, Tuition Reimbursement, and Association Membership Reimbursements.
• Flexible work schedule
• 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!
• Annual Profit Sharing Bonus (variable)
• 401(k)with employer match
• The opportunity to make a real impact on a variety of industry-leading projects.

Training + Development

Interview process

Visa Sponsorship

Security clearance