Elgin , IL 60123
Posted 3 weeks ago
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Responsible for providing technical support to operations in terms of equipment/system/process qualification, validation, requalification and change management. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while managing the regulatory requirements for change control. The ability to write protocols and reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Manages the company calibration/metrology program. Weekends and Off-shift hours are periodically required.
- Develop and maintains validation master plans, process flow diagrams, test cases, and Standard Operating Procedures (SOPs).
- Develops and improves validation programs as needed to remain current with cGMPs and industry standards.
- Represents Quality in teams assembled to specify, procure, install, qualify, validate, troubleshoot and maintain production systems, equipment and processes.
- Direct validation activities, such as protocol creation, scheduling, testing, assessment, reporting and archiving.
- Design validation study features such as sampling, testing, or analytical methodologies.
- Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, utilities, equipment, cleaning processes, computer, and new products for pharmaceutical production.
- Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
- Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols and external standards.
- Programs and operates department analytical instruments (such as temperature/humidity data loggers) to perform controlled temperature/humidity qualifications (examples warehouses, sterilizers, incubators, etc.).
- Analyze validation test data to determine whether systems or processes have met validation acceptance criteria or to identify root causes of production problems.
- Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
- Conduct audits of validation or performance qualification processes to ensure compliance with internal and regulatory requirements.
- Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventive actions (CAPA).
- Create, populate, and maintain databases for tracking validation activities and qualified/validated systems.
- Identify deviations from established product or process standards and provide recommendations for resolving deviations through technical change control and/or requalification.
- Resolve testing problems by modifying testing methods or revising test objectives and standards.
- Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
- Assist in training equipment operators and other staff on validation protocols and standard operating procedures.
- Maintain validation test equipment and manage the company calibration program, activities, scheduling and documentation.
- Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
- Other duties as assigned.
- Minimum 4-year degree in a Science or Engineering field of study; or equivalent experience.
- Generation of protocols, reports, deviations and other technical documents.
- PC literate with standard MS-Office application (Word, Excel, PowerPoint, Project, Access) competency.
- Understanding of statistical analysis tools and methods. ASQ-CQE certification preferred.
- Knowledge and understanding of cGMPs and industry guidance. Preferred 3-5 years of related experience in a cGMP facility. Pharmaceutical manufacturing experience preferred.
- Knowledge of cGMP Equipment Qualification requirements and techniques.
- Knowledge of cGMP Cleaning Validation requirements and techniques.
- Knowledge of cGMP Process and Product Validation requirements and techniques.
- Knowledge and experience in CAPA, root-cause analysis, risk assessment, investigation tools and techniques.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, and 401K with company match.