About this role
AbbVie is seeking a GMP Utility Engineer to support the operation and improvement of biopharmaceutical water and steam systems at its Worcester, MA Bioresearch Center. The role focuses on compliance, reliability improvements, troubleshooting, and execution of utility projects including installations/modifications, commissioning, and validation.
Key Responsibilities
- Serve as subject matter expert for GMP utilities supporting audits, regulatory inspections, and quality risk management
- Support ongoing operation and maintenance of GMP utilities with documentation, inspections, and Preventive Maintenance (PM) evaluations
- Provide engineering support for troubleshooting, repair planning, and system reliability improvements
- Develop scopes, estimates, specifications, and standards for utility projects
- Support equipment installations/modifications including shutdown coordination, contractor oversight, commissioning, and validation
Technical Overview
This is a GMP utilities engineering role centered on biopharmaceutical water and steam systems. The engineer will provide audit and regulatory inspection support, run compliant operation and maintenance (including inspections and Preventive Maintenance (PM) evaluations), and lead troubleshooting, repair planning, and utility project design/oversight through commissioning and validation activities.
Ideal Candidate
The ideal candidate is an engineering professional with 5+ years of significant engineering and/or operational experience supporting Good Manufacturing Practice (GMP) utilities. They act as a subject matter expert for GMP water and steam systems, lead compliant operations and maintenance, and drive troubleshooting, reliability improvements, and utility project execution. They communicate clearly across cross-functional teams and can manage multiple concurrent projects while meeting cost, scope, schedule, and financial targets.
Must-Have Skills
Good Manufacturing Practice (GMP)GMP utilitiesoperation and maintenance of GMP utilitiescompliance with applicable policiesprocedures and regulatory requirementstroubleshootingrepair planningsmall to medium-sized projects independentlymanaging multiple concurrent projects while maintaining costscopescheduleand financial targets
Nice-to-Have Skills
post-graduate education/degree
Required Skills
Good Manufacturing Practice (GMP)GMP utilitiesbiopharmaceutical water systemsbiopharmaceutical steam systemsaudit supportregulatory inspectionsinternal quality risk managementoperation and maintenanceproceduresdocumentationinspectionsPreventive Maintenance (PM) evaluationstroubleshootingrepair planningsystem reliability improvementsscopesestimatesspecificationsstandardsequipment installationsequipment modificationsshutdown coordinationcontractor oversightcommissioning activitiesvalidation activitiessmall to medium-sized projectsproject costproject scopeproject schedulefinancial targetsdesign work oversightcross-functional teams
Hard Skills
Good Manufacturing Practice (GMP)subject matter expertGMP utilitiesbiopharmaceutical water systemsbiopharmaceutical steam systemsutility equipmentaudit supportregulatory inspectionsinternal quality risk managementGlobal AbbVie Engineering alignmentoperation and maintenanceproceduresdocumentationinspectionsPreventive Maintenance (PM) evaluationscompliance with applicable policies and procedurestroubleshootingrepair planningsystem reliability improvementsscopesestimatesspecificationsstandardsutility related projectsequipment installationsequipment modificationsshutdown coordinationcontractor oversightcommissioning activitiesvalidation activitiessmall to medium-sized projectsproject costproject scopeproject schedulefinancial targetsdesign work oversightdesigns for intermediate problemscross-functional teamstask forcesstaff developmentsupervision
Soft Skills
self directedingenuityability to work across related disciplinescollaborative mindsetstrong working relationshipstactful and respectful communicationlistening to others' points of vieworal communicationwritten communicationpresentationsanalyzes complex interdisciplinary problemsjudgment within defined procedures and practicesmanage multiple concurrent projects
Keywords for Your Resume
GMP Utility EngineerGood Manufacturing Practice (GMP)GMP utilitiesbiopharmaceutical water systemsbiopharmaceutical steam systemssubject matter expertauditregulatory inspectionsinternal quality risk managementGlobal Abbvie Engineeringoperation and maintenanceproceduresdocumentationPreventive Maintenance (PM)PM evaluationstroubleshootingrepair planningsystem reliabilityscopesestimatesspecificationsstandardscommissioningvalidationshutdown coordinationcontractor oversight
Deal Breakers
Must demonstrate compliance-focused experience with GMP utilities (Good Manufacturing Practice (GMP)), Must have 5+ years of significant engineering and/or operational experience (as desired), Must be able to independently plan and execute small to medium-sized projects and manage concurrent projects
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