Sr Engineer

MWI Animal Health; Juncos (PR); On-site; USD 75,000 - 95,000; Full time

Job summary

MWI Animal Health recherche un Ingénieur Senior à Juncos, Porto Rico. Le candidat sera responsable de l'optimisation des processus et devra diriger des enquêtes sur les problèmes opérationnels tout en respectant les procédures réglementaires.

Les responsabilités incluent la gestion des contrôles de changement, le soutien aux évaluations des risques et des évaluations microbiennes, et l'assistance dans la création de documents techniques. Un doctorat ou un master avec une expérience pertinente est requis.

Qualifications

• Minimum de 2 ans d'expérience dans le secteur de l'ingénierie.
• Solides compétences en communication écrite et verbale.
• Expérience en environnement hautement réglementé.

Responsibilities

• Gérer les contrôles de changement pour les modifications de processus.
• Supporter les enquêtes sur les déviations majeures.
• Assister à la création et à la révision des enregistrements de lot.

Skills

Connaissance des processus bio-processing

Rédaction technique

Analyse des causes profondes

Documentation de bonnes pratiques (GDP)

Validations de processus

Education

Doctorat ou Master + 2 ans d'expérience

Baccalauréat en ingénierie + 4 ans d'expérience

Tools

Trackwise

Spotfire

CDOCS

Job description

## Sr EngineerPostulerlocations: Juncos, Puerto Ricotime type: Temps Pleinposted on: Publié aujourd'huijob requisition id: R269297Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!# **Job Details****Summary of Role:**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**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.**Shift:** Administrative - 8 hour shift, Mon-Fri 8am-5pm (flexibility for on-call support at any time)**Location:** Juncos, PR**Education:** Doctorate OR Masters + 2 years of Engineering experience ORBachelors in Engineering + 4 years of Engineering experience**Preferred Qualifications:*** 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**Skills:*** 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.This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.