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Process Transfer Engineer

2 months ago

Tucson, Arizona, United States R&D Partners Full time

A leading biotechnology firm is seeking a Technical Transfer Specialist to enhance Operations, Development, and Regulatory functions while facilitating the launch of new Assays, Reagents, and Bulk Materials. This role is pivotal in ensuring that all operational requirements are addressed from perspectives of manufacturability, quality, cost, and scheduling.

Key Responsibilities

  • Communicate and implement manufacturing best practices to the core project team to guarantee manufacturability and scalability.
  • Ensure that the needs of all Operations stakeholders—including Manufacturing, Process Engineering, Validations Engineering, Functional Leads, Quality, Validation, Planning, Procurement, Purchasing, and Label Control—are clearly understood and communicated throughout the transfer process.
  • Learn and apply Technology Transfer standard procedures to continuously enhance the transfer process.
  • Utilize project management techniques to plan, monitor, and ensure the timely completion of transfer projects.
  • Develop expertise in site manufacturing processes to promote, train, and enhance Good Manufacturing Practices (GMP) at the site, ensuring successful transfer activities from cost, quality, and delivery perspectives.
  • Incorporate manufacturing requirements into development projects to ensure a robust technical transfer into operations by providing input during the design phase for manufacturability.
  • Execute Validation protocols with guidance from other Technical Transfer Specialists while adhering to Good Manufacturing Processes (GMP) and standards for transferred products.
  • Engage in cross-functional teams to ensure that the objectives of the technology transfer project are met.
  • Identify and troubleshoot issues as they arise.
  • Participate in transfer planning and process updates.
  • Prepare and deliver presentations of project outcomes to diverse audiences.

Qualifications

  • Bachelor's Degree in Engineering/Engineering Technology or Life Science discipline with 1-3 years of relevant experience, or a Master's Degree in an Engineering/Engineering Technology or Life Science discipline with 0-2 years of experience.
  • Demonstrated potential for technical proficiency, scientific creativity, collaboration, and independent thought.
  • Basic understanding of assay, bulk, and reagent manufacturing processes and design, with the ability to apply scientific methods in production.
  • Strong technical writing skills for report and document creation.
  • Capability to apply Six Sigma and Lean Manufacturing methodologies during the development phase.
  • Familiarity with systems such as SAP and ETQ.

Salary Range:

  • $53,248 - $66,560

Why Choose R&D Partners?

As an employee, you will benefit from a comprehensive package that includes:

  • Medical insurance options – PPO, HMO & HSA
  • Dental & Vision insurance
  • 401k retirement plan
  • Employee Assistance Program
  • Long-term disability coverage
  • Weekly payroll schedule
  • Expense reimbursement
  • Online timecard approval system

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research, and engineering. We offer job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.