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Senior Validation Engineer

Company: Thermo Fisher Scientific
Location: Allentown
Posted on: February 26, 2021

Job Description:

COVID-19 Update: To keep our candidates, colleagues and other visitors--safe, we're making changes to our interview and hiring process. Learn more location Allentown, Pennsylvania, US Job ID: 128486BR Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com . Location/Division Specific Information Allentown, PA CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time - a concept that we internally embrace as "There is a Patient Waiting." Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters. How will you make an impact? Sr. Validation Engineer As part of our global team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer. What will you do? As a Senior Validation Engineer, you will be responsible to interact with several departments to provide validation support to validate computer systems, equipment and equipment systems, along with the critical utilities and facilities required for packaging operations at the site. You will be responsible to ensure site compliance and all necessary activities are performed on time to keep all validated systems in a validated state. How will you get here? Education

  • A four-year, Bachelor of Science degree from an accredited college or university in an Engineering or Science discipline or demonstrated equivalent experience.
  • Lead and further develop the Engineering Validation Department in conjunction with Director, Validation Engineering
  • Plan and formulate aspects of engineering projects such as objective or purpose of project, application that can be utilized from findings, cost of projects, and equipment and human resource requirements.
  • Develop, procure, and implement new technologies and innovations either through internal channels and development and/or use of outside technologies and suppliers. Modify existing processes, materials, and facilities.
  • Demonstrate sound decision making related to priorities
  • Maintain FCS validation methodology in accordance with applicable Quality/Regulatory requirements and industry best practices.
  • Lead risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes, materials, and facilities.
  • Perform technical reviews and interpret data for accuracy of equipment/process performance for completed validations/revalidations.
  • Author SOPs related to validation/revalidation activities
  • Represent validation in cross-functional meetings/projects as required
  • Ensure and/or execute proper calibration and maintenance of test equipment used for validation/revalidation of equipment and processes
  • Assist with identification and execution of master validation plan (MVP) as required
  • Work closely with engineering to coordinate and execute Factory Acceptance Testing (FAT) activities and protocols.
  • Provide constant communications with all affected departments and personnel regarding validation activities
  • Author, execute. Perform, and summarize qualification and validation activities, IQ, OQ, PQ, PV, CSV
  • Conduct root cause analysis and deviation resolution for validation exceptions
  • Perform/conduct special projects assigned by management
  • Conduct all activities in a safe and efficient manner
  • Other duties may be assigned to meet business needs Knowledge, Skills, Abilities
    • 2-5 years of validation experience in a regulated industry or equivalent validation experience including 2-5 years of food or pharmaceutical packaging or cGMP experience
    • Knowledge of regulatory requirements as applied to the qualification and management of Controlled Temperature Unit Operation
    • Knowledge of packaging materials and packaging equipment is required
    • PC literacy including the ability to generate complex documents in both Microsoft Excel and Microsoft Word
    • Must provide direction and leadership to team and external department related functions and activities
    • Must have strong interpersonal skills
    • Must have strong analytical skills
    • Must be able to multitask and respond to shifting priorities
    • Must be proficient with computer software (MS Office) and have expertise with spreadsheets
    • Must have good communication skills, both written and verbal and be able to communicate with non-validation personnel in layperson's terms
    • Must have prior mechanical and process equipment experience
    • Must be results oriented
    • Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment. Physical Requirements
      • Must be able to lift 35 pounds At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. To access this job later or share with a friend, please enter Name and Email Address below. Your Name Get notified for similar jobs Sign up and receive similar job alerts to your email Enter Email address Get customized job recommendations based on your career area of interest. How would you rate your experience popup Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com . Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Keywords: Thermo Fisher Scientific, Allentown , Senior Validation Engineer, Engineering , Allentown, Pennsylvania

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