Senior Validation Engineer
Senior Validation Engineer
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob 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 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: Masters 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 Bachelors 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.
#LIDNI
Required Experience:
Senior IC
Employment Type
Full-Time
