Interdot has over 14 years in the life science industry with allocations a cross Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative Shift (8AM to 5PM)
JOB DESCRIPTION :
Independently provides and / or directs the characterization of process optimization strategies and / or troubleshooting of operational issues, 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.
REQUIREMENTS :
Must have knowledge, at least, in one of the following software :
- MAXIMO – Owner (RSO)
- CDOCS – Editor, Owner, Reviewer, Approver, Data Verifier
- QMTS – Deviation Initiator and Owner, Change Control Owner
- GDMS – Owner
PREFER QUALIFICATIONS :
Work orders requestor, approver, may execute and document specific type of WOs (RSO) as applicableChange Controls assessor, 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 / systemsBilingual in Spanish and EnglishFUNCTIONS :
Working knowledge of pharmaceutical / biotech processes.Perform validation lifecycle activities.Work with documentation in a highly regulated environment.Operate specialized equipment and computers as appropriate.Interpret and apply GLPs and GMPs.Apply engineering science to production.Provide solutions to a large variety of technical problems of moderate to large complexity and scope.Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.EDUCATION :
Masters + 2 years of Engineering experience or bachelor's in engineering + 4 years of Engineering experiencePreferred Engineering : Mechanical, Electrical, or Chemical