Validation Engineer jobs in Wichita, KS

• Manage multiple projects / ongoing work activities within the department typically involving cross-functional representatives.
• Lead a team of full time and contract validation engineers to provide guidance on planning and execution of validation activities. Provide required technical & tactical guidance to the reporting team, completing performance management actions and regular 1:1s.
• This role is accountable for activities involved in the evaluation, review and approval of validation project plans, validation protocols and reports, and other validation lifecycle documentation.
• Develop and evaluate quality process and system standards to ensure compliance with company standards and governmental regulatory requirements.
• Investigate & troubleshoot validation problems for equipment and/or performance processes, conducting statistical analyses of testing results and process anomalies. Write, review, approve and/or implement documentation for new and current validation procedures and technical reports related to equipment, products and/or processes.
• Plans and oversees the execution of validation, technical services and improvement projects activities following applicable regulatory and Pfizer guidance. Ensure applicable VMPs and documents are maintained to GxP compliance.
• Implements department strategy, by leading cross functional projects in the design or redesign of projects.
• Ensure that appropriate systems are in place such that site operations meet or exceed the requirements.
• Provide leadership to site technical staff regarding the development of validation strategies and validation master plans for equipment, computer system, process, cleaning, facilities, utilities and manufacturing equipment.
• Present validation packages to boards of health/regulators & internal inspections.
• Allocate department staffing and manage the utilization of facilities and equipment to ensure that department and site objectives are met within budget guidelines.
• Establish governance and contributor accountability for timely project completion.
• Develop, introduce and review practices and cultural changes that enable the department to meet business demands within agreed timeframes and expected regulatory standards.

• Bachelor’s degree with 5 years of relevant validation or quality experience within the pharmaceutical industry; OR a Master’s degree with 3 years of relevant validation or quality experience within the pharmaceutical industry; OR a Ph.D. with 0-2 years of experience; OR an Associate degree with 8 years of relevant validation or quality experience within the pharmaceutical industry; OR High School Diploma (or Equivalent) with 10 years of relevant validation or quality experience within the pharmaceutical industry
• People Management experience
• Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies
• Good organizational, presentation, meeting facilitation, project/time management and technical writing skills
• Strong Analytical and problem-solving abilities

• Previous tech transfer experience.
• Extensive understanding and knowledge of regulatory requirements and validation as applied to the pharmaceutical equipment and facilities
• Background in problem solving, negotiations, data integrity principles and project management/support in a matrixed reporting environment
• Prior experience in other areas of validation (including equipment or aseptic or process validation)
• Good understanding of risk management methodologies, with a proven ability to apply to pharmaceutical operations

• 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

• Must be capable of supporting up to 10% travel (domestic and international)
• Must have the ability to work effectively under strict deadlines
• The McPherson Site is a 24/7 operation. Must be able and willing to work outside of typical business hours to support the business, which may include weekends and holidays

• Last day to apply: March 19, 2024
• Relocation support available
• Work Location Assignment: On Premise

The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. 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. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Quality Assurance and Control #LI-PFE