# Quality Assurance and Control **Company**: Pfizer **Location**: McPherson, Kansas **Work arrangement**: onsite **Experience**: senior **Job type**: full-time **Salary**: $82,700.00 to $137,900.00 **Category**: Healthcare **Industry**: Healthcare **Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---Kansas---McPherson/Senior-Validation-Engineer_4966200-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_f741ce89-3a0 ## Description Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. What You Will Achieve In this role, you will: - Lead the completion of assigned complex projects, meet agreed targets and develop plans for work activities on projects within a team. - Provide high-level data analysis support for Quality Investigations or troubleshooting. - Demonstrate comprehensive understanding of Current Good Manufacturing Practices (cGMP) guidelines outlined in Code of Federal Regulations. - Ensure compliance with the latest Pfizer Standards for validation and qualification activities. - Serve as a point contact Subject Matter Expert (SME) for routine Quality systems, such as Change Control, Quality Agreement, Documentation, Submission authoring, and Investigations. - Author or approve protocols and final reports, perform on-floor executions of validations. - Coordinate and communicate all testing with affected functional groups and evaluate test results. - Maintain Site Validation Master Plan. Support regulatory audits through preparation and interaction with auditors in areas related to sterility assurance equipment, capex qualifications, computerized systems, process or cleaning validations as assigned. - Provide expertise for troubleshooting and resolution of issues related to sterility assurance equipment, capex qualifications, computerized systems, process or cleaning validations as assigned. - Assess potential impact of changes to qualified systems. - Identify and implement validation best practices to continuously improve the site validation program. - Lead and support product transfers/new product development, regulatory queries, cost improvement projects, or Drug Product plant support for Validation. - Ensure integration of validation schedule in production schedule for implementation of validation activities and conduct validation deviations, participate in deviation investigations to identify root causes and define corrective and/or preventative actions. Support the unit where needed to assure due dates and customer needs are met. Here Is What You Need (Minimum Requirements) - Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with more than 0+ years of experience OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience. - Strong understanding of cGMPs, ISPE, Data Integrity, 21 CFR Part 11, industry good practices for IQ/OQ/PQ, and Standard Operating Procedures. - Ability to work independently with limited managerial oversight. - Strong verbal and written communication skills. Bonus Points If You Have (Preferred Requirements) - 5+ years of direct validation experience in at least one of these fields of validation: Equipment qualifications, CSV, Aseptic validations, process or cleaning validations. - Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems as related to sterile products and medical devices. - Exposure to multiple validation workstreams. PHYSICAL/MENTAL REQUIREMENTS - Requires routine sitting, standing, walking, listening, and talking. - Acute mental and visual attention at all times. - Handle multiple projects while managing frequent interruptions. - Requires moderate lifting or moving up to 25 pounds (lbs). NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS - Requires regular onsite attendance. - Must have the ability to work effectively under strict deadlines. - Must be able and willing to work beyond office hours, which may include weekends and holidays. - Must be capable of supporting up to 10% travel (domestic and international). The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental, and vision coverage. ## Skills ### Required - cGMPs - ISPE - Data Integrity - 21 CFR Part 11 - IQ/OQ/PQ ### Nice to have - validation experience - CSV - Aseptic validations - process or cleaning validations --- Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---Kansas---McPherson/Senior-Validation-Engineer_4966200-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)