Validation Engineer II

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Woodstock, IL, US

2 days ago Requisition ID: 1316

Salary Range: $85,000.00 To $90,000.00 Annually

Why Join Woodstock Sterile Solutions?

Join a team that combines deep BFS manufacturing expertise with a forward-looking commitment to operational excellence, quality, and innovation. In this role, you will help qualify and validate the equipment, processes, facilities, and utilities that support reliable sterile manufacturing and protect product integrity for customers and patients worldwide.

Position Summary

The Validation Engineer II is responsible for the design, scheduling, execution, and evaluation of scientifically and statistically sound qualification and validation studies. This role demonstrates that critical cleaning, controls, equipment, facilities, processes, and utilities function consistently and repeatably in compliance with regulatory requirements, product license restrictions, and policies affecting final product integrity.

The Validation Engineer II prepares concise technical documentation, provides validation support to Business Development, Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs, and may lead or provide validation oversight for small- to medium-sized project initiatives.

Key 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.

Qualifications

Education

Bachelor of Science degree in Engineering or a related science discipline preferred.

Experience

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.

Knowledge & Skills

Ability to interpret written, oral, diagram, and schedule-based instructions.

Ability to work independently on multiple projects and meet deadlines with limited supervision.

Strong documentation, problem-solving, analytical, and mechanical aptitude.

Detail-oriented with demonstrated initiative, sound judgment, ethical decision-making, and investigative ability.

Strong verbal, written, and interpersonal communication skills.

Ability to interact effectively with individuals and personalities across departments.

Proficiency with business computer applications, including word processing, spreadsheets, and database software.

Familiarity with cGMP and safe work practices.

Ability to read, write, and speak clear English.

Physical Requirements & Work Environment

Frequent sitting, standing, walking, reading written documents, using a computer monitor, reaching, talking, writing, and listening.

Occasional bending, grasping, carrying, stooping, kneeling, and crouching.

Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 pounds.

Fast-paced, performance-driven, customer-focused, collaborative, and inclusive work environment.