Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative Shift
Job Description:
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 & Qualifications:
- Maintenance knowledge and experience with automated and manual inspection equipment operation.
- Technical knowledge of inspection technologies for parenteral and glass containers.
- Apply sophisticated and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or projects.
- Apply standard engineering techniques and procedures to improve equipment reliability and performance.
- Interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams.
- Basic knowledge with validation and documentation processes in a highly regulated environment. Protocol Development and execution requirements.
- Work with other business functions such as research, manufacturing, process development, utilities, facilities, quality assurance and validation departments to support complex systems and/or facilities modifications.
- Technical writing and verbal communication on 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.
Education:
- Doctorate OR Masters + 2 years of Engineering experience OR bachelor’s in engineering + 4 years of Engineering experience.
- Preferred Engineering: Mechanical, Electrical, or Industrial
Skills Required
- Maintenance experience with automated and manual inspection equipment operation
- Technical knowledge of inspection technologies for parenteral and glass containers
- Apply advanced engineering principles to design and implement system modifications, experiments, and projects
- Experience improving equipment reliability and performance using standard engineering techniques
- Experience directing and interacting with mechanics, automation technicians, and IS teams
- Knowledge of validation and documentation processes in a regulated environment; protocol development and execution
- Experience with change control, deviation investigations, Root Cause Analysis, CAPA, and regulatory inspection support
- Experience supporting risk assessments, microbial assessments, and process performance evaluations
- Experience assisting with MBR creation/revisions, BOM changes, and generating technical protocols
- Technical writing and verbal communication in English and Spanish
- Doctorate OR Masters plus 2 years engineering experience OR Bachelor's in engineering plus 4 years experience
- Preferred engineering disciplines: Mechanical, Electrical, or Industrial
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
