Manufacturing Process Engineer

Equipment Requalification ConsultantsWork Location: Framingham, MA, USARole OverviewWe are seeking experienced Equipment Requalification Consultants with strong expertise in equipment qualification and GMP validation activities to support remediation and requalification programs. The ideal candidates will have hands-on experience with IQ/OQ/PQ, CQV, GMP validation, equipment lifecycle management, deviations, and CAPA within regulated environments.Key ResponsibilitiesLead and execute equipment requalification activities.Prepare, review, and execute qualification protocols and reports.Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.Support Commissioning, Qualification, and Validation (CQV) activities across production equipment, facilities, and utility systems.Identify, document, investigate, and manage deviations associated with qualification activities.Support Corrective and Preventive Actions (CAPA) related to equipment and validation issues.Ensure compliance with GMP requirements throughout the equipment lifecycle.Maintain accurate and compliant qualification and validation documentation.Collaborate closely with Engineering, Manufacturing, Quality, and Validation teams.Support remediation initiatives and ensure equipment remains in a qualified and validated state.Required SkillsEquipment RequalificationEquipment QualificationIQ/OQ/PQCommissioning, Qualification & Validation (CQV)GMP ValidationEngineeringUtilities & FacilitiesEquipment Lifecycle ManagementDeviation ManagementCAPA ManagementQualification Protocols & ReportsGMP ComplianceAll qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.