✦ Luna Orbit — Engineering (Non-Software)

Engineering Specialist - Commissioning, Qualification, and Validation (CQV)

at Merck

📍 USA - New Jersey - Rahway Hybrid 💰 $87K – $137K USD / year Posted March 21, 2026
Salary $87K – $137K USD / year
Type Not Specified
Experience mid
Exp. Years 2+ years
Education Bachelor's degree in engineering or science
Category Engineering (Non-Software)

Leads commissioning, qualification, and validation activities for pharmaceutical equipment and systems, ensuring compliance with cGMP standards and supporting quality assurance efforts.

  • Develop validation protocols
  • Execute commissioning activities
  • Perform risk assessments
  • Lead FMEA and CAPA processes
  • Maintain validation documentation

Environment involves validation master planning, risk assessments, FMEA, CAPA, and computerized validation systems like Kneat, supporting pharmaceutical manufacturing operations.

The ideal candidate is a mid-level engineer with experience in commissioning, qualification, and validation processes within pharmaceutical manufacturing, familiar with cGMP standards and risk assessment methodologies.

CommissioningQualificationValidationcGMPRisk Assessment
KneatCalibration Management SystemsComputerized Maintenance Management SystemsFMEACAPA
KneatCCMSCMMS
CommissioningQualificationValidationcGMPValidation Master PlansRisk AssessmentFMEACAPARoot Cause AnalysisCMMSCCMSCalibration ManagementComputerized Systems
CommissioningQualificationValidationcGMPValidation Master PlansProject ExecutionRisk AssessmentFMEACAPARoot Cause AnalysisCMMSCCMSCalibration ManagementComputerized Systems
Organizational SkillsCommunicationLeadershipProblem SolvingTeamwork
Industry Pharmaceutical / Healthcare
Job Function Ensuring equipment and process validation compliance in pharmaceutical manufacturing
Role Subtype Engineering Specialist
Tech Domains Validation, Commissioning, Qualification, Process Engineering
CommissioningQualificationValidationcGMPValidation Master PlansRisk AssessmentFMEACAPARoot Cause AnalysisCMMSCCMSCalibration ManagementComputerized SystemsGMPProcess ValidationEquipment QualificationQuality Systems

Lack of experience in validation or commissioning, No knowledge of cGMP standards, Inability to perform risk assessments, No experience with validation systems like Kneat, Unwillingness to work in a regulated environment

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