Validation Engineer II – GMP, Protocols & Cross-Functional Lead

Woodstock Sterile Solutions; Woodstock (IL); On-site; USD 80,000 - 110,000; Full time

Job summary

Woodstock Sterile Solutions is seeking a Validation Engineer II to design, schedule, execute, and evaluate qualification and validation studies ensuring cleanability, controls, equipment, and facilities meet regulatory and quality requirements. You will prepare technical documentation and may lead small- to medium-sized projects.

The role demands strong documentation, problem solving, and communication skills, with collaboration across Business Development, Engineering, Manufacturing, QA, QC,

Qualifications

• Bachelor of Science degree in Engineering or related science preferred.
• Bachelor’s degree in Engineering or related physical science with 3+ years of experience; master’s considered.
• Knowledge of cGMPs, pharmaceutical manufacturing methods, and validation principles.
• Strong documentation and analytical skills; English proficiency.

Responsibilities

• Serve as validation representative or PM on cross-functional teams.
• Research regulatory requirements and ensure subjects meet specs.
• Prepare validation study protocols with specifications and acceptance criteria.
• Schedule and coordinate validation study execution with departments.
• Prepare documentation dossiers summarizing results and conformance.
• Support validation policies, SOPs, and quality standards; assist inspections.

Skills

Independent work

Documentation

Problem solving

Attention to detail

Communication skills

Cross-functional collaboration

MS Office proficiency

cGMP knowledge

English proficiency

Education

BS in Engineering or related science

Master's degree may be considered

Job description

Woodstock Sterile Solutions is seeking a Validation Engineer II to design, schedule, execute, and evaluate qualification and validation studies ensuring cleanability, controls, equipment, and facilities meet regulatory and quality requirements. You will prepare technical documentation and may lead small- to medium-sized projects.

The role demands strong documentation, problem solving, and communication skills, with collaboration across Business Development, Engineering, Manufacturing, QA, QC,