Sr Engineer 34420

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 applicable
• Change Controls assessor, 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
• Bilingual in Spanish and English

FUNCTIONS:

• 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 experience
• Preferred Engineering: Mechanical, Electrical, or Chemical