Job Description

Job Title: Validation Engineer

Location: Lawrence, KS

Job Summary:

We are seeking a Validation Engineer to support process and equipment changes, system implementations, and product transfers at our pharmaceutical manufacturing site in Lawrence, KS. This contract role involves hands-on validation activities, project coordination, and cross-functional collaboration to support quality and operational excellence.

Key Responsibilities:

• Serve as a technical representative for engineering and validation on new systems and equipment.
• Develop and review User Requirement Specifications (URS), and perform FAT/SAT commissioning activities.
• Write and execute IQ/OQ/PQ validation protocols for equipment, utilities, processes, and cleaning systems.
• Lead and support capital projects aimed at improving efficiency, quality, and safety.
• Develop and manage project plans, timelines, and budgets, reporting on progress and resolving issues.
• Collaborate with production and product development teams to support process improvement and new product introductions.
• Participate in continuous improvement and Kaizen initiatives.
• Ensure compliance with EHS, cGMP, and relevant regulatory guidelines.

Required Qualifications:

• Bachelor’s degree in Engineering or related field.
• Minimum 2 years of hands-on validation experience in utilities, equipment, processes, or cleaning systems within the pharmaceutical industry.
• Familiarity with sterile aseptic liquid filling operations.
• Strong communication and interpersonal skills.
• Proficient in producing clear and professional technical documentation and presentations.

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