Validation Engineer II: Drive Quality & Compliance Impact

Woodstock Sterile Solutions; Woodstock, Northern (IL, KY); Hybrid; USD 85,000 - 90,000; Full time

Job summary

Woodstock Sterile Solutions in Woodstock, IL is seeking a Validation Engineer II to lead the design, scheduling, execution, and evaluation of qualification studies ensuring devices and processes meet regulatory requirements and product integrity.

The role involves preparing concise technical documentation, supporting multiple departments, and potentially leading validation initiatives within cross-functional teams.

Qualifications

• Bachelor’s degree in Engineering or a closely related physical science with at least three years of directly related experience, or an equivalent combination of education, experience, and training.
• A master’s degree with at least two years of related experience may be considered.
• Knowledge of current Good Manufacturing Practices (cGMPs), direct pharmaceutical manufacturing methods, and validation principles.
• Ability to interpret written, oral, diagram, and schedule-based instructions.
• Strong documentation, problem-solving, analytical, and mechanical aptitude.
• Detail-oriented with demonstrated initiative, sound judgment, ethical decision-making, and investigative ability.

Responsibilities

• Serve as a validation representative and, when assigned, Validation Project Manager on cross-functional project teams.
• Research applicable governmental and regulatory requirements for assigned projects and ensure study subjects meet required specifications.
• Prepare scientifically sound validation study protocols incorporating defined specifications, acceptance criteria, and assessment procedures.
• Schedule and coordinate validation study execution with the appropriate departments.
• Provide validation oversight for small- and medium-sized project initiatives.
• Prepare detailed documentation dossiers summarizing experimental results, specifications, and conformance to defined acceptance criteria.
• Develop and execute complex procedures and methods with a high level of quality.
• Prepare test plans as required by Equipment Change Orders.
• Maintain close communication with Business Development, Engineering, and Manufacturing regarding validation challenges and opportunities.
• Provide technical support to Business Development, Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs as needed.
• Assist with development of validation policies, programs, SOPs, and quality standards that meet industry, quality, and external regulatory requirements.
• Support the facility during internal and external inspections.
• Work directly with management, contract customers, and contract engineers.
• Maintain the effectiveness of Quality System components relevant to the position.
• Identify, evaluate, and manage risk to ensure product quality.
• Perform other duties as assigned.

Skills

Documentation

Problem-solving

Analytical

Mechanical aptitude

Communication

Cross-functional collaboration

Education

Bachelor of Science in Engineering

Master's degree (related field)

Tools

Word processing

Spreadsheets

Database software

Job description

Woodstock Sterile Solutions in Woodstock, IL is seeking a Validation Engineer II to lead the design, scheduling, execution, and evaluation of qualification studies ensuring devices and processes meet regulatory requirements and product integrity.

The role involves preparing concise technical documentation, supporting multiple departments, and potentially leading validation initiatives within cross-functional teams.