Validation Engineer

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.