Home Jobs Validation Engineer
Back to Jobs

Validation Engineer - Job Opportunity at Stem DTS

Indianapolis, US
Contract
Mid-level
Posted: February 26, 2025
On-site
USD 104,000-124,800 per year

Benefits

Comprehensive health insurance with competitive coverage
Dental plan with preventive care focus
Flexible PTO policy promoting work-life balance

Key Responsibilities

Lead CQV implementation for 60,000 sq. ft. GMP facility, ensuring regulatory compliance and operational excellence
Direct validation strategies for specialized pharmaceutical production areas, impacting product quality and safety
Drive continuous improvement initiatives through deviation investigation and CAPA management
Develop and execute technical documentation for GMP operations, supporting regulatory compliance
Support health authority inspections and maintain quality metrics

Requirements

Education

BS or MS in Life Sciences / STEM

Experience

3+ Years

Required Skills

GMP operations CQV documentation Process validation Quality control Deviation investigation CAPA management Technical writing Project management
Advertisement
Ad Space

Sauge AI Market Intelligence

Industry Trends

The radiopharmaceutical sector is experiencing rapid growth due to increasing demand for targeted cancer therapies and diagnostic solutions, creating sustained demand for validation expertise GMP facility expansion projects are accelerating across the US, particularly in biotech hubs, driving competition for qualified validation engineers Regulatory scrutiny in radiopharmaceutical manufacturing is intensifying, elevating the importance of validation roles

Salary Evaluation

The offered compensation of $50-60/hr ($104,000-124,800 annually) aligns with market rates for mid-level validation engineers in the Midwest, though slightly below rates in major biotech hubs

Role Significance

Typically part of a 5-8 person validation team in a mid-sized pharmaceutical facility, collaborating closely with QA/QC and operations
Mid-level position with significant operational impact, serving as a key technical resource for GMP compliance and facility qualification

Key Projects

Facility commissioning and qualification for new GMP spaces Process validation for radiopharmaceutical production Quality system implementation and maintenance Regulatory inspection preparation and support

Success Factors

Deep understanding of GMP requirements and radiopharmaceutical manufacturing processes Strong technical writing and documentation skills Ability to manage multiple validation projects simultaneously Effective cross-functional collaboration skills

Market Demand

High demand with sustained growth projected. The specialized nature of radiopharmaceutical validation expertise creates a competitive talent market with limited qualified candidates.

Important Skills

Critical Skills

GMP compliance expertise is essential for ensuring regulatory requirements are met Technical writing capabilities directly impact validation documentation quality Project management skills are crucial for managing multiple validation activities

Beneficial Skills

Understanding of radiopharmaceutical manufacturing processes Experience with quality management systems Knowledge of regulatory inspection preparation

Unique Aspects

Opportunity to work on full facility qualification from ground up
Exposure to specialized radiopharmaceutical manufacturing processes
Combination of technical validation and GMP compliance responsibilities

Career Growth

2-3 years in role typical before advancement, accelerated by successful facility qualification completion

Potential Next Roles

Senior Validation Engineer Validation Manager Quality Systems Manager Technical Operations Lead

Company Overview

Stem DTS

Stem DTS operates in the specialized radiopharmaceutical manufacturing sector, focusing on GMP-compliant production facilities

Growing presence in the radiopharmaceutical contract manufacturing space, with strategic facility investments
Indianapolis location positions the company within a growing Midwest biotech corridor
Professional environment with emphasis on regulatory compliance and technical excellence
Advertisement
Ad Space
Apply Now

Data Sources & Analysis Information

Job Listings Data

The job listings displayed on this platform are sourced through BrightData's comprehensive API, ensuring up-to-date and accurate job market information.

Sauge AI Market Intelligence

Our advanced AI system analyzes each job listing to provide valuable insights including:

  • Industry trends and market dynamics
  • Salary estimates and market demand analysis
  • Role significance and career growth potential
  • Critical success factors and key skills
  • Unique aspects of each position

This integration of reliable job data with AI-powered analysis helps provide you with comprehensive insights for making informed career decisions.