Endo · 22 hours ago
Sr. Validation Engineer
Triangle Area
Full-time
Onsite
Senior Level
5+ years expEndo is committed to improving lives through quality healthcare and teamwork. The Sr. Validation Engineer will prepare and execute validation projects for pharmaceutical API manufacturing, ensuring compliance with regulations and supporting manufacturing, packaging, and quality control processes.
Pharmaceuticals
Responsibilities
Prepare and execute validation projects for all aspects of pharmaceutical API manufacturing to include Equipment Validation, Equipment Requalification, Process Validation, Packaging Validation, Cleaning Validation, Computer System Validation, and Data Integrity Analysis
Coordinates with cross-functional resources in the execution of cleaning validation projects and ensures compliance with FDA, EU, JP cGMP and any other appropriate regulations
Supports manufacturing, packaging and quality control with new equipment validation, process improvements, review and approval of change control documentation, review of exceptions related to deviations from cleaning processes and provides technical support as required
Ensures product quality through robust testing and process monitoring including use of statistical process control techniques, Six Sigma tools, understanding of current compliance and technology trends, and application of related pharmaceutical experience
Assists with multiple cross-functional projects from development through release to production
Manage manufacturing and laboratory equipment requalification program
Assist in the management, support and continued development of the Cleaning Validation Program
Generate protocols, equipment swab diagrams, product risk assessments and general technical reports related to cleaning validation
Independently execute activities in support of the Validation Department cleaning validation program priorities with minimal guidance from the department manager
Establish and/or extend clean and soiled hold times
Analyzes data, utilizing appropriate statistical methods, generated by studies performed by the Validation Department to determine process capabilities
Support any deviations encountered associated with validation activities
Execute validations as needed, including assisting in product sampling, auditing and technical review functions as defined in study protocols
Review and approve change control documentation to assure all validation requirements are detailed in the Action Items
Ensures compliance with data integrity requirements
Develops protocols using engineering experience and statistical process controls
Prepares and maintains validation records in accordance with department procedures to ensure compliance with current standards
Evaluates effectiveness of SOPs, identifies changes that would enhance the process, and ensures alignment with corporate procedures
Ensures compliance with FDA regulations and assists in audits
Stays current with regulatory requirements and creates remediation plans
Drives continuous improvement to stay aligned with industry trends
Works cross-functionally with team, other departments, and corporate validation to support improvements
Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness
Willing to challenge current practices
Experienced with using tools like an FMEA to use a risk based approach to determine and prioritize actions
Qualification
Required
Bachelor Degree in engineering discipline or technical field related to pharmaceutical manufacturing is preferred or Associates Degree with equivalent combination of education, experience, and competencies may be considered
Minimum of 5-10 years of previous validation experience in pharmaceutical manufacturing, with an emphasis on process and cleaning validation
Strong computer literacy—MS office products, statistical analysis (Minitab) and database usage
Knowledge of statistical process controls is also required for equipment qualifications
Strong communication skills
Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies
Project Management: Manages projects according to a standard process by using a systems development lifecycle; effectively directs and integrates all aspects of a project or program, ensuring that work progresses toward achieving goals and objectives; achieves expected results through the successful and timely completion of activities; at the end of a project, with project team, takes time to determine what was learned that can be applied to future projects
Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action
Preferred
Extensive experience with process and cleaning validation
Strong technical and mathematical aptitude
Training or certifications in regulatory and cGMP requirements is desired
Knowledge of FDA regulated drug validation requirements including knowledge of cGMP regulations in parts 201 and 2011, and FDA 21 CFR Part 11
Company
Endo
Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.
Founded in 1997Malvern, , US
1001-5000 employeesFunding
Current Stage
Late StageLeadership Team
Blaise Coleman
President and Chief Executive Officer
Jennifer Lynn Fernandez
Sr. Executive Coordinator to President and CEO
Recent News
2025-09-23
2025-09-22
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