Senior Validation Project Lead/Manager

Position : Senior Validation Project Lead/Manager - Life Sciences Group Location : Midwest US (Traveling) Company Overview : Compli, LLC was founded in 2001 to provide Commissioning, Validation, and Regulatory Support Services to the Life Sciences industry. We serve pharmaceutical companies across the United States, offering a wide range of services to help clients meet their goals. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc., integrating a comprehensive suite of in-house services. We specialize in Commissioning, Qualification, Regulatory Compliance, and On-Demand services. Supervisory Responsibilities : None Essential Functions : Support client commissioning and validation for facilities, utilities, equipment, cleaning, and process validation projects. Prepare and execute validation lifecycle documents. Participate in various stages of clinical or commercial production, including construction, renovation, product development, launch, or upgrades. Write summary reports for validation and qualification protocols. Support project milestones, priorities, and deadlines. Develop operating procedures for equipment and practices. Perform risk assessments and analyses of systems and processes. Coordinate protocol execution with other departments such as manufacturing, facilities, and project management. Create project-specific validation plans and strategies. Manage and execute multiple projects simultaneously. Apply practical problem-solving approaches. Represent Compli at client sites and interact confidently with clients, contractors, management, and peers. Perform other duties as assigned. Education & Experience : Bachelor's degree in a related life sciences field or equivalent industry training and experience. Minimum of 7 years of CQV experience with aseptic liquid filling facilities, utilities, and systems. Technical Skills & Abilities : Ability to discuss scientific matters effectively. Ability to work independently or collaboratively. Deep understanding of validation principles, practices, and standards. Subject Matter Expert (SME) in at least one validation area. Proficiency in current Good Manufacturing Practices and regulations. Experience with industry best practices (e.g., ISPE) and lifecycle deliverables (UR, SRS, FRS, DDS, RTM, UAT, FAT, SAT, Validation Planning, IQ, OQ, PQ, Validation Summary). Expertise in system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR). Excellent technical writing skills. Proficiency in MS Word, Excel, PowerPoint, and Project. Physical Requirements : Prolonged sitting and working at a computer. Ability to lift up to 15 pounds. Travel : Willingness to travel regionally and nationally within the Eastern and Midwest US. Salary Range : $120,000 to $150,000 annually. At Compli, we value innovative and intelligent problem-solvers. We are committed to technical excellence and creating solutions that improve quality of life. We are industry leaders in integrating design, construction, and technology. We are an Equal Employment Opportunity Employer, promoting diversity and inclusion regardless of race, color, religion, sex, sexual orientation, gender identity, age, marital status, genetic information, veteran status, or any other protected status.

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