Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives for as many people as possible. With 30 years of technological expertise, we are a world leader in sterile single-dose products, with 10 sites across 4 continents and more than 2000 employees. Since 2013, our site Unither Manufacturing LLC. in Rochester (NY) specializes in manufacturing Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets, and Capsules. It has over 280 employees. Your role Reporting to the Quality Director , Job Summary: This is a team-oriented position involving coordination, communication, and collaboration across multiple departments. You will perform validation activities related to computer systems, ensuring systems are maintained in a validated state. Responsibilities include developing validation project plans, risk assessments, and other qualification and validation activities such as equipment qualifications, utility recertifications, cleaning recertifications, and sterile process recertifications. Essential Functions and Responsibilities: Computer Systems Validation Activities (50%) Review and develop User Requirement Specifications, Functional and Design Specifications, and manage validation project plans and protocols. Collaborate with departments to develop risk assessments, controls, and mitigation strategies. Develop, write, and execute qualification protocols ensuring compliance with FDA 21 CFR part 11 and Annex 11, including system and user acceptance testing. Compile and organize validation documentation for audits and regulatory review. Create SOPs specific to computer system validation, including updates and changes. Qualification Protocols and Documentation (30%) Develop and execute qualification protocols for manufacturing, processing, and packaging equipment and facilities. Ensure validation activities are incorporated into project plans, including resources and timelines. Collect and review relevant documentation and investigate deviations or exceptions. Coordinate with IT, Operations, Engineering, QA, and Product Development to ensure validation activities are completed. Validation Protocols and Documentation (20%) Write validation protocols for process validations. Prepare final reports following validation criteria. Perform sampling and testing as per protocols, review results, and maintain documentation. Stay updated with industry practices and modify protocols accordingly. Your profile Education & Experience: Bachelor’s degree in science or engineering preferred; associate degree with relevant experience considered. Minimum 3 years of validation, GMP, or regulated environment experience for those with an associate degree; co-op/internship experience preferred. Experience in IT or OT departments is a plus. 0-2 years relevant experience if educational requirements are not met. Knowledge, Skills, & Abilities: Stay updated on cGMP validation trends and standards. Effective communication skills, both written and oral. Ability to manage multiple projects and adapt to scope and timeline changes. Understanding of FDA validation requirements and Annex 11. Ability to analyze and interpret data. Scope of Decision-Making: Routine analytical judgment within standard procedures. Supervision: May lead project teams, assign, review, and check work. Contacts: Regular internal and external contacts, including customers and clients. Physical & Environmental Requirements: Office environment with visits to manufacturing areas. Prolonged computer work, safety gear, and gowning required. Transporting validation samples and meeting project deadlines. Compensation Range: $65,000 - $75,000 USD *Salaries are determined based on various factors including experience, education, and internal policies. Join us and make a difference! #J-18808-Ljbffr Unither Pharma
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