mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.
Job Description
Independently provides and / or directs the characterization of process optimization strategies and / or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and / or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
Preferred Qualifications
Must have, at least, the following Amgen systems Knowledge :
- a. MAXIMO – Owner (RSO)
- b. CDOCS – Editor, Owner, Reviewer, Approver, Data Verifier
- c. QMTS – Deviation Initiator and Owner, Change Control Owner
- d. GDMS – Owner
Prefer Qualifications :
Work orders requestor, approver, may execute and document specific type of WOs (RSO) as applicableChange Controls assessorChange Control development & presenterCAPA proposal and implementation plan development & presenterURS’s, RD’s, DS’s reviewer / approver / ownerMaintenance Master Package (MMP) reviewer / approver / ownerTest Runs / Protocols (PTCs) reviewer / approver / execution and / or support (may be author in very specific cases)FAT's / SAT's author / reviewer / approver / execution and / or supportFunctional tests author / reviewer / approver / execution and / or supportIOQ / PQ reviewer / execution and / or supportP&ID and official drawings reviewer / approver / ownerSOP & Forms : author / reviewer / approver / owner (equipment systems), reviewer (process)Job Plans development, reviewer and maintenanceSpare parts reviewer, approver and maintenanceProvide troubleshooting support as required by operations / engineeringAnalyze downtime incidents as per Equipment Failure, prepare recommendations, create action plans and execute to eliminate recurrenceParticipate actively in the support of High Skills equipment breakdowns, which could impact the operation with an extensive downtimePerform or review equipment / system Root Cause Analysis investigationsParticipate in risk assessment and continuous improvement initiatives (Kaizens, critiques, VSMs)Generate or support the generation of One-point-lessons for systems / equipmentIdentify, evaluate, develop / design, plan and implement solutions for equipment / process improvement opportunitiesDevelopment, execution and implementation of corrective and preventive actions (CAPAs)Assist in generation of training materials and in providing training on scientific, technical operations aspects of the equipment / systemsEducation
Bachelor’s Degree in Mechanical Electrical o Chemical Engineering.Skills
Fully BilingualGood interpersonal skillsComputer literateGood oral and written communication skillsThis Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
