Validation Specialist Engineering jobs in United States
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Merck · 10 hours ago

Validation Specialist Engineering

Merck is a leading global healthcare company, and they are seeking a Validation Specialist to support validation execution activities at their West Point site. The role involves preparing, reviewing, and executing validation documentation for manufacturing projects, as well as managing ongoing validation activities and training personnel.

BiotechnologyHealth CareMedicalPharmaceutical
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Comp. & Benefits
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Responsibilities

Manage validation needs and deliverables for ongoing Validation activities as assigned to specialist
Work closely with IPT management to ensure safe, on-time, and correct execution of validation activities
Interface with site Validation SMEs to ensure validation practices are aligned with our Company network
Support site IPTs during investigations and troubleshooting
Support all aspects of the Continuous Validation Program

Qualification

Validation processesValidation applicationsValidation testing techniquesMicrosoft OfficeVaccine ManufacturingApplied EngineeringAutomationCollaborative CommunicationsData AnalysisEquipment TroubleshootingManufacturing Practices (GMP)Process OptimizationProduction OperationsProfessional IntegrityRoot Cause Analysis (RCA)Technology TransferAdaptabilityDocumentation ReviewProject ManagementTechnical WritingWriting Technical Documents

Required

BS, Preferably in Engineering or Sciences
Minimum of 2 years of relevant work experience, hands on experience on validation activities on sterile products manufacturing
Knowledge and hands on experience with Validation processes
Familiarity of different types of Validation applications
Familiarity of compliant validation testing techniques
Strong communication, collaboration skills and ability to drive accountability
Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.)
Adaptability
Applied Engineering
Automation
Collaborative Communications
Data Analysis
Documentation Review
Equipment Troubleshooting
Good Manufacturing Practices (GMP)
Microsoft Office
Process Optimization
Production Operations
Professional Integrity
Project Management
Root Cause Analysis (RCA)
Technical Writing
Technology Transfer
Vaccine Manufacturing
Validation Testing
Writing Technical Documents

Preferred

Experience working on cross-functional team to achieve common goal
Experience writing validation assessments
Experience using KNEAT/eVal

Benefits

Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days

Company

Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.

Funding

Current Stage
Public Company
Total Funding
$5.59M
Key Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO

Leadership Team

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Betty Larson
Executive Vice President and Chief Human Resources Officer
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Dean Li
Executive Vice President and President, Merck Research Laboratories
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Company data provided by crunchbase