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Manufacturing Operations Support Lead; Hybrid

Job in Oak Ridge, Anderson County, Tennessee, 37831, USA
Listing for: Oak Ridge National Laboratory
Full Time position
Listed on 2026-07-27
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Position: Manufacturing Operations Support Lead (Hybrid)
Requisition

Overview:

We are seeking a Manufacturing Operations Support Lead who will lead the development, governance, and continuous improvement of controlled documentation program by translating complex scientific, engineering, operational, quality, and regulatory requirements into controlled technical documentation that enables the safe, compliant, and efficient production of radioisotopes. This position serves as the primary interface between multidisciplinary organizations and production operations by integrating engineering intent, process knowledge, operational practices, quality requirements, and regulatory expectations into clear, accurate, and executable documentation.

Working collaboratively with scientists, engineers, operators, quality professionals, maintenance personnel, and other subject matter experts, the Manufacturing Operations Support Lead develops and maintains production procedures, process descriptions, technical manuals, work instructions, forms, and other controlled documents that define how isotope production is safely and effectively performed. This role supports operational excellence by improving documentation quality, standardizing technical information, preserving institutional knowledge, facilitating knowledge transfer, and driving continuous improvement across isotope production operations.

This position resides in the Operations Support Group in the Isotope Processing and Manufacturing Division (IPMD), Isotope Science and Enrichment Directorate (ISED) at Oak Ridge National Laboratory (ORNL).

The Operations Support Group provides operational excellence, process improvement, and technical support for ORNL's world-class radioisotope production program. IPMD is responsible for the safe and reliable production of radioisotopes that support medical, industrial, research, and national security missions. Production activities are conducted in glove boxes, shielded hot cells, and radiological facilities across the ORNL campus.

Major Duties/Responsibilities:

* Serve as the Operations organization's lead for documentation strategy by translating complex scientific, engineering, operational, quality, and regulatory requirements into controlled documentation that supports safe and effective isotope production.

* Lead the planning, development, revision, implementation, and lifecycle management of production procedures, process descriptions, technical manuals, work instructions, forms, and other controlled operational documentation.

* Lead multidisciplinary document development efforts involving scientists, engineers, operators, quality assurance personnel, maintenance organizations, and other subject matter experts to produce technically accurate, executable documentation.

* Lead document reviews, technical verifications/validations, approvals, and change management activities to ensure documentation remains current, technically accurate, and compliant with applicable requirements.

* Partner with Safety, Security, Operations, Nuclear Facilities, Performance Assurance, and Quality personnel to establish a close working relationship to ensure that IPMD adheres to programmatic requirements (e.g., DOE Writers Guide, Safety Basis Technical Specifications, Quality Assurance Program [NQA-1] and DOE O 422.1, Conduct of Operations, for nuclear and non-nuclear documents).

* Develop documentation standards, templates, and best practices that improve consistency, usability, operational effectiveness, and knowledge transfer across isotope production.

* Lead continuous improvement initiatives by improving documentation processes, incorporating lessons learned, capturing operational feedback, and implementing documentation enhancements that improve operational performance.

* Provide technical editing for reports, operational plans, training materials, engineering documentation, assessments, and other technical communications supporting isotope production.

* Manage multiple technical documentation and operational support projects, establishing priorities that align with production schedules, organizational objectives, and strategic initiatives.

* Work closely with Operations Support Group Leader…
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