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.
1st Shift (6:00 a.m. - 2:30 p.m.)
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:
- Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
- Develop engineering policies and procedures that affect multiple organizational units.
- Coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
- Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
- Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
- Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
- Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
- Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
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
