Senior Process Engineer, Bioprocess & Compliance

Inteldot; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Inteldot in Puerto Rico seeks an Administrative Shift engineer to independently characterize process optimization strategies and troubleshoot operations in manufacturing, pilot plant, or capital projects. Applies engineering principles to major system modifications; develops analysis and presents results for issues of significant scope.

Requires education in Life Sciences and Engineering, strong root cause analysis, lean manufacturing, GDP, Trackwise/Spotfire/CDOCS familiarity, and fluency in

Qualifications

• Educational background in Life Sciences and Engineering.
• 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

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.

Skills

Root Cause Analysis

Lean Manufacturing

GDP (GxP)

Communication

Technical Writing

Bilingual EN/ES

Bio-processing

Process Monitoring

Trackwise

Spotfire

CDOCS

Education

Doctorate

Masters + 2 yrs Eng

Bachelors + 4 yrs Eng

Tools

None

Job description

Inteldot in Puerto Rico seeks an Administrative Shift engineer to independently characterize process optimization strategies and troubleshoot operations in manufacturing, pilot plant, or capital projects. Applies engineering principles to major system modifications; develops analysis and presents results for issues of significant scope.

Requires education in Life Sciences and Engineering, strong root cause analysis, lean manufacturing, GDP, Trackwise/Spotfire/CDOCS familiarity, and fluency in