Requisition Id 16793

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 gloveboxes, 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 and Division Leadership on other special planning and departmental projects.
• Advise Group Leaders, Section Heads, and Division Leadership on documentation governance, process standardization, and operational improvement initiatives.
• Deliver ORNL's mission by aligning behaviors, priorities, and interactions with our core values of Impact, Integrity, Teamwork, Safety, and Service. Promote equal opportunity by fostering a respectful workplace - in how we treat one another, work together, and measure success.

Basic Qualifications:

• A BS degree in Technical Communication, English, Engineering, Physical Sciences, or a related discipline.
• A minimum of 8 years of experience developing technical documentation within a highly regulated technical, manufacturing, or nuclear environment, or an equivalent combination of education and applicable experience.
• Demonstrated experience developing, revising, and maintaining complex technical procedures, process descriptions, operational documentation, and controlled technical documents.
• Demonstrated understanding of DOE Order 422.1, Conduct of Operations, Human and Organizational Performance (HOP), document control principles, and quality assurance requirements within regulated environments.
• Demonstrated ability to interpret scientific, engineering, operational, and regulatory requirements and translate them into technically accurate, executable documentation.
• Experience coordinating multidisciplinary document development efforts involving engineers, scientists, operators, quality assurance personnel, and other technical subject matter experts.
• Strong analytical, organizational, problem-solving, and technical communication skills.
• An understanding of manufacturing, quality, and maintenance processes.
• Ability to work and communicate (written and oral) effectively with diverse teams of engineers, scientists, and technicians.
• Proficiency with Microsoft Office products and electronic document management systems.
• Ability to obtain and maintain a DOE security clearance.

Preferred Qualifications:

• Experience supporting DOE nuclear facilities or highly regulated manufacturing operations.
• Working knowledge of DOE Order 422.1, NQA-1, Conduct of Operations, Safety Basis documentation, Human and Organizational Performance (HOP), document verification and validation, work control, configuration management, and records management.
• Procedure Professionals Association (PPA) Procedure Writer certification.
• Experience developing process descriptions, technical manuals, operational standards, engineering documentation, and training materials.
• Experience supporting isotope production, radiochemical processing, nuclear operations, manufacturing, or research facilities.
• Experience developing documentation governance programs, documentation standards, or organizational documentation strategies.
• Motivated self-starter with the ability to work independently and to participate creatively in collaborative teams across the laboratory.
• Ability to function well in a fast-paced production environment, set priorities to accomplish multiple tasks within deadlines, and adapt to ever changing needs.
• Active DOE Q Clearance.

Special Requirements:

• Visa sponsorship is not available for this position.
• This position requires the ability to obtain and maintain a clearance from the Department of Energy. As such, this position is a Workplace Substance Abuse (WSAP) testing designated position. WSAP positions require passing a pre-placement drug test and participation in an ongoing random drug testing program.

This position is located in Oak Ridge, Tennessee and requires onsite presence. We offer a flexible work environment that supports both the organization and the employee. A hybrid/onsite working arrangement may be available with this position, which provides flexibility to work periodically from your home, while reporting onsite to the Oak Ridge, Tennessee location on a weekly and regular basis.

Please note that the pay range information is a general guideline only. Many factors are taken into consideration when setting starting pay. Salary for this position will be commensurate with the final candidate's qualifications and experience, including skills, knowledge, relevant education, certifications, plus also aligned with the internal peer group. It is not typical for an individual to be offered a salary at or near the top of the range for a position. Link to benefits. https://jobs.ornl.gov/content/Benefits/?locale=en_US

This position will remain open for a minimum of 5 days after which it will close when a qualified candidate is identified and/or hired.

We accept Word (.doc, .docx), Adobe (unsecured .pdf), Rich Text Format (.rtf), and HTML (.htm, .html) up to 5MB in size. Resumes from third party vendors will not be accepted; these resumes will be deleted and the candidates submitted will not be considered for employment.