Job Description Sr Engineer with experience in regulated industries. Duties: Work orders requestor, approver, may execute and document specific type of WOs (RSO).
Change Controls assessor.
Change Control development & presenter.
CAPA proposal and implementation plan development & presenter.
URS's, RD's, DS's reviewer / approver /owner.
Maintenance Master Package (MMP) reviewer / approver / owner.
Test 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 support.
Functional tests author / reviewer / approver / execution and/or support.
IOQ / PQ reviewer / execution and/or support.
P&ID and official drawings reviewer / approver / owner.
SOP & Forms: author / reviewer / approver /owner (equipment systems), reviewer (process).
Job Plans development, reviewer and maintenance.
Spare parts reviewer, approver and maintenance.
Provide troubleshooting support as required by operations / engineering.
Analyze downtime incidents as per Equipment Failure, prepare recommendations, create action plans and execute to eliminate recurrence.
Participate actively in the support of High Skills equipment breakdowns, which could impact the operation with an extensive downtime.
Perform or review equipment / system Root Cause Analysis investigations.
Participate in risk assessment and continuous improvement initiatives (Kaizens, critiques, VSMs).
Generate or support the generation of One-point-lessons for systems / equipment.
Identify, evaluate, develop / design, plan and implement solutions for equipment / process improvement opportunities.
Development, 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 / systems.
Must have, at least, the following systems knowledge: MAXIMO – Owner (RSO) CDOCS – Editor, Owner, Reviewer, Approver, Data Verifier QMTS – Deviation Initiator and Owner, Change Control Owner GDMS – Owner Requirements Doctorate degree or Master's degree and 3 years of Engineering experience or Bachelor's degree in Engineering and 5 years of Engineering experience Bilingual (Spanish/English) Technical Writing Shift: 8hrs shift | 8AM a 5PM Monday to Friday Requirements Bachelor in Engineering