JT693 - SR. ENGINEER

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA
 

Responsibilities:

• 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.
• Work orders requestor, approver, may execute and document specific type of WOs (RSO) as applicable
• 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

Qualifications:

• Bachelor Degree in Engineering 
• Five (5) years of Previous experience in Engineering
• Knowledge in systems:
  a. MAXIMO – Owner (RSO)
  b. CDOCS – Editor, Owner, Reviewer, Approver, Data Verifier
  c. QMTS – Deviation Initiator and Owner, Change Control Owner
  d. GDMS – Owner
• Availability for 1st shift (8AM a 5PM Monday to Friday)