Sr Engineer

Cencora•Juncos, PR

2d•Onsite

About The Position

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.

Requirements

Doctorate OR Masters + 2 years of Engineering experience OR Bachelors in Engineering + 4 years of Engineering experience
In-depth experience of bio-processing unit operations
Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe)
Familiar with Lean Manufacturing Practices
Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
Proficiency in GDP (Good Documentation Practices) on a regulated environment
Knowledge in systems: Trackwise, Spotfire, CDOCS, and process monitoring platforms
Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish
Working knowledge of pharmaceutical/biotech processes
Familiarity with validation processes
Familiarity with documentation in a highly regulated environment
Ability to operate specialized laboratory equipment and computers as appropriate.
Ability to interpret and apply GLPs and GMPs.
Ability to apply engineering science to production.
Able to develop solutions to routine technical problems of limited scope
Problem solving and applied engineering.
Basic technical report writing
Verbal communication
Comprehensive understanding of validation protocol execution requirements.

Responsibilities

Own change controls for manufacturing process changes
Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.
Support Risk Assessments exercises and Microbial assessment evaluations.
Led commercial campaign readiness and effectively communicate and collaborate with cross function areas.
Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process.
Provide commercial support when needed and assist on the floor troubleshooting.
Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness.
Generate technical protocols as needed.
Assist and provide guidance during MBR (Master Batch Record) creation/revisions.
Perform assessment to support process, automation, or equipment modification or implementation of special projects
Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
Assess process performance and review of performance data.
Evaluate, plan, and implement solutions for process improvement opportunities.
Complete assessments for CAPA applicability requests from other plants/sites
Complete assessment for new or changes in BOM's (Bill of Materials)
Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.