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Senior Validation Engineer

Location Allentown, ペンシルバニア州, アメリカ合衆国 Job Id R-01303233 Job Type フルタイム Category オペレーション Remote すべてオンサイト
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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

COMPANY:                            Thermo Fisher Scientific, Inc.

LOCATION:                            7554 Schantz Rd., Allentown, PA 18106

TITLE:                                    Senior Validation Engineer

HOURS:                                  Monday to Friday, 8:00 am to 5:00 pm

DUTIES:                                 Provide validation support to validate computer systems, equipment and equipment systems, and critical utilities and facilities required for packaging operations.

                                                Ensure site compliance and all necessary activities are performed on time to keep all validated systems in a validated state.

                                                Plan and formulate aspects of engineering projects such as objective or purpose of project, applications that can be utilized from findings, cost of projects, and equipment and human resources requirements.

                                                Develop, procure, and implement new technologies and innovations through internal channels and development and/or use of outside technologies and suppliers.

                                                Modify existing processes, materials, and facilities.

                                                Maintain FCS validation methodology in accordance with 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.

                                                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).

                                                Work with engineering to coordinate and execute Factory Acceptance Testing (FAT) activities and protocols.

                                                Author, execute, perform, and summarize qualification and validation activities, IQ, OQ, PQ, PV, and CSV.

                                                Conduct root cause analysis and deviation resolution for validation exceptions.

TRAVEL:                                Up to 10% domestic and international travel required.

REQUIREMENTS:                  Master’s degree or foreign degree equivalent in Chemical Engineering, Manufacturing Engineering or related field of study plus 3 years of validation experience in a regulated industry or related experience. Employer will also accept a Bachelor’s degree or foreign degree equivalent in Chemical Engineering, Manufacturing Engineering, or related field of study plus 5 years of validation experience in a regulated industry or related experience as an equivalent alternative.

                                                Required knowledge or experience with:

  • Regulatory requirements as applied to the qualification and management of Controlled Temperature Unit (CTU) Operation;
  • Lifecycle of Validation documentation;
  • Microsoft Excel and Word;
  • IQ, OQ, PQ, PV, and CSV; and
  • Factory Acceptance Testing (FAT) activities and protocols.

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