Overview
Remote
Full Time
Skills
Mergers and acquisitions
Performance management
Project management
Preventive maintenance
PQ
Management
Documentation
IQ
OQ
Statistics
Collaboration
Laboratory equipment
Instrumentation
UPS
Process improvement
Technical communication
Industrial engineering
Mechanical engineering
Verification and validation
Agile
Statistical process control
Analysis of variance
Data Analysis
Minitab
JMP
Quality control
Analytical skill
HPLC
Spectroscopy
FTIR
Manufacturing
Good manufacturing practice
ISO 13485
Regulatory Compliance
Continuous improvement
5S
Job Details
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
COMPANY: Thermo Fisher Scientific Inc.
LOCATION: 168 Third Avenue, Waltham, MA 02451
TITLE: Engineer III, Validation
HOURS: Monday to Friday, 8:00 am to 5:00 pm
DUTIES: Draft validation protocols for method crossovers and performance qualification for QC instruments;
Create instrument qualification packages using Kneat (e-validation software);
Draft Unit Operational Procedures (UOPs), Qualification package (IQ/OQ/PQ) for the new QC lab instrument and equipment in Kneat and engineering change requests in Agile;
Review and compile the documentation for the QC lab instrument and equipment;
Maintain, supervise and review documentation for the execution of IQ and OQ activities for vendors;
Perform statistical analysis using Minitab on historical data to support the site;
Independently plan and execute experiments, data analysis and interpretation;
Collaborate with other teams to coordinate and resolve quality related issue;
Maintain and troubleshoot laboratory equipment and instrumentation as needed;
Support activities for lab expansions, scale-ups, and process improvement projects;
Produce and present original technical communication materials for internal and external stakeholders.
TRAVEL: Up to 10% domestic or international travel required. Can work remotely or
telecommute.
REQUIREMENTS: MINIMUM Education Requirement:
Master's degree, or foreign equivalent, in Industrial Engineering, Mechanical Engineering or a related field of study.
MINIMUM Experience Requirement:
3 years of experience in instrument qualification, software validation or related experience.
Alternative Education and Experience Requirement:
Bachelor's degree, or foreign equivalent in Industrial Engineering, Mechanical Engineering, or a related field of study plus 5 years of experience in instrument qualification, software validation or related experience.
Required knowledge or experience with:
Minitab, Kneat and Agile;
SPC, t-tests, ANOVA using Statistical data analysis (Minitab, JMP) for qualification and method transfer activities for QC Method;
Instrumental analysis including analytical HPLC, spectroscopy, FTIR and Particle size;
Manufacturing Practices (cGMP), 21 CFR Part 11 and ISO 13485 compliance requirements;
Continual process improvement practices such as Kaizens, Gemba, 3P, 5S, Standard Work and others.
#LI-DNI
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
COMPANY: Thermo Fisher Scientific Inc.
LOCATION: 168 Third Avenue, Waltham, MA 02451
TITLE: Engineer III, Validation
HOURS: Monday to Friday, 8:00 am to 5:00 pm
DUTIES: Draft validation protocols for method crossovers and performance qualification for QC instruments;
Create instrument qualification packages using Kneat (e-validation software);
Draft Unit Operational Procedures (UOPs), Qualification package (IQ/OQ/PQ) for the new QC lab instrument and equipment in Kneat and engineering change requests in Agile;
Review and compile the documentation for the QC lab instrument and equipment;
Maintain, supervise and review documentation for the execution of IQ and OQ activities for vendors;
Perform statistical analysis using Minitab on historical data to support the site;
Independently plan and execute experiments, data analysis and interpretation;
Collaborate with other teams to coordinate and resolve quality related issue;
Maintain and troubleshoot laboratory equipment and instrumentation as needed;
Support activities for lab expansions, scale-ups, and process improvement projects;
Produce and present original technical communication materials for internal and external stakeholders.
TRAVEL: Up to 10% domestic or international travel required. Can work remotely or
telecommute.
REQUIREMENTS: MINIMUM Education Requirement:
Master's degree, or foreign equivalent, in Industrial Engineering, Mechanical Engineering or a related field of study.
MINIMUM Experience Requirement:
3 years of experience in instrument qualification, software validation or related experience.
Alternative Education and Experience Requirement:
Bachelor's degree, or foreign equivalent in Industrial Engineering, Mechanical Engineering, or a related field of study plus 5 years of experience in instrument qualification, software validation or related experience.
Required knowledge or experience with:
Minitab, Kneat and Agile;
SPC, t-tests, ANOVA using Statistical data analysis (Minitab, JMP) for qualification and method transfer activities for QC Method;
Instrumental analysis including analytical HPLC, spectroscopy, FTIR and Particle size;
Manufacturing Practices (cGMP), 21 CFR Part 11 and ISO 13485 compliance requirements;
Continual process improvement practices such as Kaizens, Gemba, 3P, 5S, Standard Work and others.
#LI-DNI
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