mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.
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
- 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.
- Supervise, 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.
- Application of mature engineering knowledge in planning and conducting projects.
- Other functions may be assigned
- Design Engineering :
- Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
- Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and / or highly complex system / facility modifications
- 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.
- Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project
Preferred Qualifications
Experience with equipment and / or process troubleshooting in a regulated environment.Knowledge of pharmaceutical / biotech processes and GMP production operations.Organizational & technical writing skills.Proficient presentation & communication skills in English and SpanishProvide solutions to a variety of technical problems of moderate scope and complexity.Under general supervision will evaluate, select and apply standard engineering techniques, basic principles and procedures. Assistance given for unusual problems.Function as a technical expert to process, equipment and / or systems during troubleshooting operations and multi-functional discussions.Frequently become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems.Routinely supervise manufacturing processes for performance indicators and operations.Suggest problem resolution and provide troubleshooting mentorship.Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and / or validation departments in developing requirements andrecommendations for process and / or system modifications.
Support the execution of manufacturing / quality systems such as deviations, equipment qualification and / or process validation, procedures, training, and new product introductions.Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity.Apply basic engineering principles to the design and implementation of system modifications, experiments and / or capital projects.Support 7 / 24 non-standard shift operation including extended hours and weekends as per business needs.Education :
Master degree OR Bachelor degree in Engineering & 2 years of Engineering experienceEducational background in Mechanical, Electrical and / or Chemical EngineeringEducation This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.