Validation Engineer II - Quality Systems & Compliance

ADP, Inc.; Woodstock (IL); On-site; USD 85,000 - 90,000; Full time

Job summary

Woodstock Sterile Solutions is seeking a Validation Engineer II to design, schedule, and evaluate qualification and validation studies, ensuring regulatory compliance and product integrity. You will prepare technical documentation and provide validation support across departments, potentially leading project initiatives.

The role requires a BS in engineering or related science, 3+ years of experience (master’s with 2+ years considered), and strong knowledge of cGMPs along with excellent

Qualifications

• Bachelor of Science degree in Engineering or related science.
• 3+ years of directly related experience; master’s with 2+ years may be considered.
• Knowledge of cGMPs and pharmaceutical manufacturing methods.
• Strong documentation, problem-solving, analytical, and communication skills.

Responsibilities

• Design, scheduling, execution, and evaluation of qualification/validation studies.
• Prepare validation study protocols with specs and acceptance criteria.
• Coordinate validation study execution with departments.
• Provide validation oversight for small- and medium-sized projects.
• Prepare detailed dossiers summarizing results and conformance to criteria.
• Develop complex procedures and methods with high quality.

Skills

cGMP knowledge

Analytical thinking

Documentation skills

Project coordination

English proficiency

Education

Bachelor of Science in Engineering or related science

Master's degree considered

Job description

Woodstock Sterile Solutions is seeking a Validation Engineer II to design, schedule, and evaluate qualification and validation studies, ensuring regulatory compliance and product integrity. You will prepare technical documentation and provide validation support across departments, potentially leading project initiatives.

The role requires a BS in engineering or related science, 3+ years of experience (master’s with 2+ years considered), and strong knowledge of cGMPs along with excellent