Find & Apply For Validation Engineer Jobs in Sugar Land, Texas

POSITION PURPOSE

This position is responsible for managing the company's validation program for all Kavis' products to include validation of computer systems, cleaning processes, manufacturing processes, packaging processes. Maintaining a continuous state of validation of manufacturing processes in accordance with regulatory regulations and guidelines; improving robustness and efficiency of manufacturing processes resulting in optimal right first time ("RFT") and cost competitiveness; providing technical expertise and product stewardship to support the overall plant's performance meeting or exceeding safety, quality, customer service and cost targets. Ensure that all technical work meets the company's procedures and standard of quality and compliance as well as customer needs are addressed promptly and proactively. Perform job functions in accordance with Standard Operating Procedures (SOPs), the Food and Drug Administration (FDA) regulations, Current Good Manufacturing Practices (cGMP), and the Occupational Safety and Health Administration (OSHA) and other duties as assigned.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this position successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties. 1. Provide leadership to ensure that equipment, systems, and processes are qualified/validated in compliance with regulatory requirements and company standards. 2. Manage validation and qualification projects through full lifecycles, including planning, execution, reporting, and timely achievement of milestones. 3. Develop, maintain, and update the site Validation Master Plan to ensure alignment with current regulatory expectations. 4. Collaborate cross-functionally to execute PPQ and product launch activities, serving as the primary QA/Validation interface with internal and external partners. 5. Write, review, and approve validation documentation, including protocols, reports, and vendor/contractor deliverables. 6. Execute validation and qualification activities including equipment qualification, time-based and event-driven requalification, cleaning validation and verification, CSV, and CPV support while maintaining audit-ready documentation and statistical rigor. 7. Oversee and support validation studies for equipment, utilities, facilities, cleaning, and computerized systems (21 CFR Part 11). 8. Provide technical input into system specifications, procurement, commissioning, and change control processes. 9. Track, trend, and report on validation, qualification, calibration, and maintenance programs to ensure compliance and efficiency. 10. Apply risk-based approaches to validation activities, ensuring robust, compliant, and efficient programs that meet regulatory and customer expectations. 11. Serve as a subject matter expert to support complex investigations, regulatory inspections, and post-approval submissions. 12. Stay current with regulatory guidance and industry trends, sharing insights with site leadership to maintain best practices. 13. Promote standardization and continuous improvement in validation methodologies, documentation, and processes.

QUALIFICATIONS

The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

KNOWLEDGE A

unique combination of technical and leadership skills, administrative management, and teamwork to effectively service and communicate with all internal / external validation customers. Must possess knowledge of validation processes and requirements. Familiarity with computers and Microsoft Office software such as MS Word, Excel, Access, and Project Management.

SKILLS AND ABILITIES

Must possess strong verbal and written communication skills and a well-developed ability to constructively work across functional areas to achieve results. Ability to multi-task a large number of projects and evaluate priorities with minimal supervision.

SUPERVISION

Position functions autonomously. Position could directly supervise employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; succession planning; rewarding and disciplining employees; addressing complaints and resolving problems.

EDUCATION/EXPERIENCE

Minimum of a Bachelor's degree in Engineering or related science degree from an accredited 4-year college. Advanced degree desirable. A minimum of six years of related experience required. Semi-solids, liquids, formulation, and manufacturing experience preferred. However, a combination of experience and/or education will be taken into consideration.

LICENSES/CERTIFICATIONS

None required.

LANGUAGE SKILLS

Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute rate, ratio and percent and to draw and interpret graphs.

REASONING ABILITY

Ability to solve problems with a variety of variables. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform essential duties. The position physical demands are sitting at a desk or table for periods of time, standing, or walking. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Light lifting requirements.

WORK ENVIRONMENT

The work environmental characteristics described here are representative of those an employee encounters while performing the essential duties of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform essential duties. The position will work in a normal office, but will include going to laboratories, manufacturing or warehouse areas.