Validation Engineer II: GMP Compliance & Validation Lead

Woodstock Sterile Solutions; Woodstock (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

Woodstock Sterile Solutions is seeking a Validation Engineer II to design, schedule, execute, and evaluate qualification and validation studies to ensure sterile products meet regulatory and license requirements. You will prepare concise technical documentation, provide validation support to Engineering, Manufacturing, QA, QC, and Regulatory Affairs, and may lead or oversee small- to medium-sized projects.

The role requires strong analytical and communication skills with a disciplined focus on

Qualifications

• Bachelor's degree in Engineering or related science required.
• Master's degree may be considered.
• Knowledge of cGMP and pharmaceutical validation.
• Strong documentation and analytical skills.
• Ability to read, write, and speak English clearly.

Responsibilities

• Serve as validation representative and, when assigned, Validation Project Manager on cross-functional project teams.
• 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.
• Maintain close communication with Business Development, Engineering, and Manufacturing regarding validation challenges and opportunities.
• Assist with development of validation policies, programs, SOPs, and quality standards that meet industry, quality, and external regulatory requirements.

Skills

Documentation

Analytical thinking

Problem solving

Effective communication

Multitasking

Team collaboration

Education

Bachelor of Science in Engineering

Master's degree in related field

Tools

Word processing

Spreadsheets

Database software

Job description

Woodstock Sterile Solutions is seeking a Validation Engineer II to design, schedule, execute, and evaluate qualification and validation studies to ensure sterile products meet regulatory and license requirements. You will prepare concise technical documentation, provide validation support to Engineering, Manufacturing, QA, QC, and Regulatory Affairs, and may lead or oversee small- to medium-sized projects.

The role requires strong analytical and communication skills with a disciplined focus on