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.