Senior Nuclear Manufacturing Engineer

Jobtailor; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Jobtailor in Indianapolis, IN seeks an experienced Project Manager to coordinate and integrate technical activities across engineering projects. You will manage SAP documentation, design changes, and large project scopes, ensuring regulatory compliance and cross-functional collaboration.

The role requires independence, team collaboration, and a strong understanding of FDA/EMA/ISO/NRC regulations within pharmaceutical manufacturing contexts.

Qualifications

• Bachelor's degree or equivalent experience in related field preferred.
• 2+ years related work experience preferred.
• Ability to work independently and as a member of a team.
• Strong understanding of regulatory requirements, including FDA (21 CFR Parts 210, 211, 820), EMA, ISO standards, and NRC regulations relevant to nuclear pharmaceutical manufacturing preferred.

Responsibilities

• Manages the coordination and overall integration of technical activities in engineering projects.
• Manages SAP and work order documentation for the department.
• Designs mechanical changes to manufacturing machines.
• Directs, reviews, or approves project design changes.
• Documents design changes.
• Evaluates processes and identifies areas for improvement.
• Coordinates with quality and validation on design changes in the applicable facilities/production lines.
• Oversees and project manages large engineering projects.
• Serves as the technical lead for internal and external engineering teams.
• Manages projects from start to end from both a resource management and outcome perspective.
• Leads teams as necessary without being a people manager.

Skills

Project Management

Mechanical Design

Process Evaluation

Work Order Documentation

Design Change Documentation

Education

Bachelor's degree or equivalent experience in related field

Tools

SAP

Job description

• Manages the coordination and overall integration of technical activities in engineering projects
• Manages SAP and work order documentation for the department
• Designs mechanical changes to manufacturing machines
• Directs, reviews, or approves project design changes
• Documents design changes
• Evaluates processes and identifies areas for improvement
• Coordinates with quality and validation on design changes in the applicable facilities/production lines
• Oversees and project manages large engineering projects
• Serves as the technical lead for internal and external engineering teams
• Manages projects from start to end from both a resource management and outcome perspective
• Leads teams as necessary without being a people manager

Requirements

• Bachelors degree or equivalent experience in related field preferred
• A minimum of 2+ years related work experience preferred
• Ability to work independently and as a member of a team
• Strong understanding of regulatory requirements, including FDA (21 CFR Parts 210, 211, 820), EMA, ISO standards, and specifically NRC regulations relevant to nuclear pharmaceutical manufacturing preferred
• Excellent written and verbal communication skills for effective collaboration with diverse teams and stakeholders
• Ability to work independently, manage multiple priorities, and make sound decisions with minimal supervision

Core Competencies

Demonstrates expertise in managing engineering projects, including coordination of technical activities, design changes, and regulatory compliance in the pharmaceutical manufacturing sector. Proven ability to lead teams and manage projects from inception to completion while ensuring effective communication and collaboration across diverse stakeholders.

Highest-signal resume keywords

• Project Management
• Regulatory Compliance
• Mechanical Design
• Team Leadership
• Process Improvement

Hard Skills

• Project Management
• Mechanical Design
• Process Evaluation
• Work Order Documentation
• Design Change Documentation

Soft Skills

• Excellent Communication
• Independent Work
• Team Collaboration
• Decision Making
• Prioritization

Industry Keywords

• FDA Regulations
• ISO Standards
• NRC Regulations
• Pharmaceutical Manufacturing
• Engineering Projects

Tools & Technologies

• SAP