Kennesaw, GA, 31144, USA
16 hours ago
Validation Manager - Kennesaw, GA
**106573BR** **Job Title:** Validation Manager - Kennesaw, GA **Department/Function:** Operations: Manufacturing, Production, Maintenance, Utilities **Job Description:** **Validation Manager - Kennesaw, GA** The Validation Manager is responsible for ensuring that equipment, utilities, systems, and processes are validated and maintained in a compliant state in accordance with FDA regulations, cGMP requirements, and site-specific quality standards. **Key Responsibilities** + Develop, review, execute, and approve validation and qualification deliverables, including User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for production and quality equipment, utilities, and systems. + Oversee the validation lifecycle for equipment and systems, ensuring that all activities are scientifically sound, appropriately justified, and thoroughly documented. + Review validation data, protocols, reports, technical specifications, and supporting documentation to verify accuracy, completeness, and compliance with regulatory and internal requirements. + Maintain the Validation Master Summary (VMS) by adding new validation activities, updating existing records, and retiring obsolete entries to ensure an accurate representation of the facility’s validated state. + Support the development, review, and maintenance of calibration protocols and records for equipment impacting product quality, ensuring alignment with validation expectations and regulatory requirements. + Review, trend, and manage equipment calibration and requalification activities, evaluate calibration results, and identify recurring issues or risks to the validated state. + Participate in change control activities by reviewing and approving changes that affect validated equipment, systems, or processes, including performing validation impact assessments as required. + Support and review investigations and corrective and preventive actions (CAPAs) related to validation, qualification, or equipment performance, ensuring appropriate root cause analysis and effective follow‑up actions. + Plan, execute, review, and evaluate temperature mapping and environmental qualification studies for warehouses and production areas; prepare summary reports documenting compliance with acceptance criteria. + Provide guidance, training, and subject matter expertise to cross-functional teams on validation principles, procedures, and best practices. + Participate on project teams supporting new equipment installations, system upgrades, and process changes to ensure validation requirements are integrated throughout the project lifecycle. + Perform other validation-related duties as assigned to support site quality and compliance objectives. + May serve on additional project or cross-functional teams as needed. **Education** + Bachelor’s Degree in Engineering, Chemistry, Food Technology, Biotechnology, Pharmaceutical Sciences, or a related scientific or technical field. **Experience** + Minimum of 1+ years of quality experience in an FDA-regulated environment. + Minimum of 1+ years of experience with CAPA, nonconformances, or related quality investigations. **Required Skills & Competencies** + Ability to evaluate complex situations and develop practical, compliant solutions. + Hands-on experience with equipment qualification and validation (IQ, OQ, PQ). + Strong analytical abilities and competence in data interpretation. + Ability to manage multiple priorities in a fast‑paced environment. + Excellent written and verbal communication skills. + Strong attention to detail in documentation and execution of validation activities. + Self-directed, proactive, and able to take ownership of assigned tasks. + Ability to quickly learn new equipment, systems, and processes. + Proficiency with Microsoft Office applications, especially Excel. + Strong organizational, time‑management, and teamwork skills. + Results-driven with a strong work ethic. + Ability to follow GMP procedures and site work instructions. + Experience supporting deviations, investigations, and corrective actions. + Familiarity with change control processes. Excited about this role but don’t think you meet every requirement listed? We encourage you to apply anyway. You may be just the right candidate for this role or another one of our openings. ADM requires the successful completion of a background check. REF:106573BR **Req/Job ID:** 106573BR **City:** Kennesaw **State:** GA - Georgia **Ref ID:** \#LI-AM1 **:** **About ADM** At ADM, we unlock the power of nature to provide access to nutrition worldwide. With industry-advancing innovations, a complete portfolio of ingredients and solutions to meet any taste, and a commitment to sustainability, we give customers an edge in solving the nutritional challenges of today and tomorrow. We’re a global leader in human and animal nutrition and the world’s premier agricultural origination and processing company. Our breadth, depth, insights, facilities and logistical expertise give us unparalleled capabilities to meet needs for food, beverages, health and wellness, and more. From the seed of the idea to the outcome of the solution, we enrich the quality of life the world over. Learn more at www.adm.com. **:** \#LI-Onsite **\t:** **\#IncludingYou** Diversity, equity, inclusion and belonging are cornerstones of ADM’s efforts to continue innovating, driving growth, and delivering outstanding performance. We are committed to attracting and retaining a diverse workforce and create welcoming, truly inclusive work environments — environments that enable every ADM colleague to feel comfortable on the job, make meaningful contributions to our success, and grow their career. We respect and value the unique backgrounds and experiences that each person can bring to ADM because we know that diversity of perspectives makes us better, together. We welcome everyone to apply. We are committed to ensuring all qualified applicants receive consideration for employment regardless of race, color, ethnicity, disability, religion, national origin, language, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law **:** **Benefits and Perks** Enriching the quality of life for the world begins by taking care of our colleagues. In addition to competitive pay, we support your diverse needs with a comprehensive total rewards package to enhance your well-being, including: + **Physical wellness** – medical/Rx, dental, vision and on-site wellness center access or gym reimbursement (as applicable). + **Financial wellness** – flexible spending accounts, health savings account, 401(k) with matching contributions and cash balance plan, discounted employee stock purchasing program, life insurance, disability, workers’ compensation, legal assistance, identity theft protection. + **Mental and social wellness** – Employee Assistance Program (EAP), Employee Resource Groups (ERGs) and Colleague Giving Programs (ADM Cares). Additional benefits include: + Paid time off including paid holidays. + Adoption assistance and paid maternity and parental leave. + Tuition assistance. + Company-sponsored training and development resources, such as LinkedIn Learning, language training and mentoring programs. *Benefits may vary for bargained locations, confirm benefit eligibility with your recruiter. **:** Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. If hired, employees will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. The pay range for this position is expected to be between: **:** x **Salaried Incentive Plan:** The total compensation package for this position will also include annual bonus
Confirmar seu email: Enviar Email