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Project Engineer

3 months ago

Rio Rancho, United States Nature's Toolbox, Inc. Full time

Nature's Toolbox (NTx) in Rio Rancho, NM, is establishing a Manufacturing Technology (MT) team within Commercial Operations to oversee the production of enzymes for use in NTx' innovative cell-free platforms for the manufacture of mRNA, saRNA, proteins, and other biologics. NTx technology will transform how biologic therapeutics are manufactured and replace the status quo.

Your Impact

The Project Engineer will report to the V.P of Manufacturing and oversee the build-out of internal capacity and capability for manufacturing of NTx biopharmaceutical materials.

Your Responsibilities

Equipment Specification and Design:

  • Define the specifications for capital equipment like chromatography systems, buffer formulation units, virus filtration setups, and oligonucleotide synthesis machines.
  • Design or oversee the design of these systems, ensuring they meet both production needs and regulatory requirements.
  • Manage the specification, design, manufacture, and qualification of custom and standard capital equipment used for pharmaceutical and biopharmaceutical product manufacturing (example equipment types include fermentation, chromatography, buffer formulation, synthetic organic chemistry)
Project Management:
  • Collaborate on projects from conception through to completion, ensuring they are delivered on time, within budget, and to the required quality standards with project management.
  • Coordinate with cross-functional teams, including R&D, production, and quality assurance, to ensure project alignment with business objectives.
  • fully manage and direct project requirements and specifications for all of project team
  • manage project timelines and budgets
  • Specify appropriate components and materials in accordance with project requirements, subject matter expertise for process and design points (calculations and sizing), and consideration of vendor selection, component suitability and availability, price, and lead time
  • Develop and manage project schedule and communicate schedule updates and critical paths with stakeholders
Manufacturing and Procurement:
  • Work closely with manufacturing teams and external suppliers to oversee the fabrication of equipment.
  • Recommend vendors and support the procurement processes / contract negotiations for equipment and related services.
  • make sound component and sub-supplier selections
Quality Assurance and Compliance:
  • Ensure all equipment complies with industry standards such as FDA regulations, GMP (Good Manufacturing Practices), and other relevant guidelines.
  • Work with the quality assurance team to validate equipment and processes.
  • Advise Quality Control on specifications for component receipt and acceptance specific to a project
  • Execute testing activities including mechanical, electrical, and automation commissioning, GAMP qualification, customer Factory Acceptance Testing and customer Site Acceptance Testing
Equipment Qualification and Validation:
  • Lead the qualification (IQ, OQ, PQ) of new equipment, ensuring it operates within specified parameters and meets all necessary regulatory requirements.
  • Working with Process Engineering, develop and execute validation protocols and reports.
  • commission and validate assembled equipment
  • Ensure that project scope is completely accounted for and supervise adequate packaging of all deliverables in preparation for transport
Technical Leadership and Support:
  • Provide technical expertise in the areas of pharmaceutical and biopharmaceutical manufacturing equipment.
  • Serve as the primary stakeholder and owner of customer equipment projects
  • Provide technical and practical expertise to support Project Manager
  • Offer ongoing support and troubleshooting for equipment-related issues.
Documentation and Reporting:
  • Maintain thorough documentation for all stages of the project, including design specifications, manufacturing records, and qualification reports.
  • Prepare and present project updates to senior management and stakeholders.
  • Create and / or review design documents, including technical drawings and specification documents
  • Write and execute detailed project-specific test protocols in accordance with GAMP and established templates and practices
  • Construct user manuals and other customer-facing documents to comply with project requirements and realize customer satisfaction
  • Perform engineering review of final documentation turnover packages
Continuous Improvement:
  • Stay abreast of technological advancements in pharmaceutical equipment and processes.
  • Propose and implement improvements to existing systems to enhance efficiency, safety, and compliance.
  • Contribute to new product designs with innovative ideas, practical design feedback, and product risk/benefit analyses
Cross-Functional Collaboration:
  • Liaise with other departments such as supply chain, regulatory affairs, and maintenance to ensure equipment and projects align with overall operational goals.
  • Identify, clarify, and manage project scope internally and with customer, facilitating change orders as necessary
  • Communicate project budget for labor and materials and manage actively throughout the project to maximize project margin
Safety and Environmental Compliance:
  • Ensure all activities comply with environmental, health, and safety regulations.
External Communications
  • interface effectively with customer stakeholders
  • Review and understand detailed customer specifications and interpret requirements to appropriate stakeholders
  • Travel to customer site for supervision of installation, testing of installed equipment, and operator training
Your Education
  • Degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, or other related discipline.
Your Experience, Knowledge, and Skills
  • Minimum of 10 years building or operating process equipment (preferably in pharmaceutical industry) •Licensed Professional Engineer not required, but considered a plus
  • Familiarity with Quality Management Systems (ISO 9001:2015 preferred) and current Good Manufacturing Practices
  • Experience with fermenter design, depth filtration, centrifugation, homogenization chromatography and TFF.
  • Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, experience building relationships with and working with CDMOs.
  • Experience in preparing CMC documentation for regulatory submissions a plus.
  • Experience with DOE and statistical software.
  • Ability to travel, ~30% (domestic and international).
Working Conditions & Physical Requirements
  • The working environment is generally favorable and consists of a laboratory environment.
  • Lighting, temperature and noise levels are adequate.
  • Personal Protective Equipment is required where stated. This includes a lab coat, hair/beard net, safety glasses, and gloves.
  • While performing the duties of this job, the employee is frequently required to sit, stand and walk to the different lab areas.
  • The employee is regularly required to lift and/or move materials or equipment up to 25 lbs.
  • Frequent use of hands to manipulate, handle or touch objects, tools or controls.
  • Specific vision abilities required by this job include vision, color vision, depth perception, and ability to adjust focus.
  • Employee may be exposed to moving mechanical parts, fumes or airborne particles and chemicals.

This position will be hybrid with preferred areas being in Rio Rancho, NM or the Dallas Metro area.

At Nature's Toolbox, we are a small team of great minds with an even larger vision. Join us today and contribute to change how lifesaving therapeutics are manufactured today.

Nature's Toolbox Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.

NTx is not accepting unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to NTx, including unsolicited resumes sent to a NTx mailing address, email address, directly to NTx employees, or to NTx's resume database will be considered NTx property. NTx will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. NTx will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.