Sr. Validation Engineer

Endo•Raleigh, NC

About The Position

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day. Job Description Summary 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

Assists with multiple cross-functional projects from development through release to production.
Projects include new facilities startup, manufacturing equipment and packaging line FATs and qualifications.
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.