Process Calibration Engineer

hace 6 días

Provincia de Cartago, Costa Rica Coloplast A tiempo completo

**Ubicación**:
Cartago, Costa Rica, CR

**Familia de puestos**: Control de Calidad

**País**: Costa Rica

Job function summary

Process Calibration Engineer routinely ensures test of equipment and instruments to check that the reading and output meet expected results. If a deviation is found, Process Calibration Engineer will ensure that the equipment will be further analysed, adjusted, and repaired, as necessary, additionally that the non-conformance process is initiated and followed according to the instructions. The primary job is to ensure that calibration is done correctly, accurate readings are given, and in a timely manner as well as maintain the qualified state of laboratory equipment, controlled environmental rooms and clean rooms according to the given specification, internal and external requirements.

Major areas of accountability

**Conducting calibration of production - and test equipment for**: daily plans, transfer, commissioning or modification projects etc.
Providing information and proposing to modify, schedule and execute the calibration plan, if required by changes in process parameters.
Supporting troubleshooting equipment failures (out of specification / expected ranges).
Installation of equipment or parts, when performing calibration.
Routine testing, calibration, and monitoring of equipment.
Analysis and interpretation of calibration data.
Ordering of parts and calibration services from external suppliers.
Organizing calibration responsible and supplier activities within the site.
Ensure the CAR site reaches corporate KPI targets.
Ensure the CAR site compliance with the Local and Corporate procedures.
Performing tasks and developments in accordance with the professional specialization.
Following, issuing and updating internal calibration processes and developing of calibration tools such as protocols, reports and spreadsheets due to business need in alignment with corporate requirements and external regulations.
Ensuring local training if necessary and aligning with global and local processes.
Participation in meetings necessary to align local and global processes and provide feedback to process owners, commissioning team, pilot team, transfer team and quality team.
Active participation in calibration process improvements.
Provide timely feedback and proposed solution when any risk in the Calibration process occurs.
Handling of non-conformities found within the calibration system according to Coloplast procedures and KPI.
Handling Change Control activities according to Coloplast procedures and KPI.
Active support on Qualification of local pieces equipment and tools owns by the Quality Department
Perform activities related to validation and revalidation of Cleanrooms such as (but not limited): defining strategies with stakeholders (Microbiology, Facilities, Production teams), issuing protocols, reports and measuring activities.
Participate in the as Calibration representative in external and internal audits as needed.
Perform activities related to qualification of control rooms and laboratory equipment such as (but not limited): defining strategies, measuring of conditions, and issuing reports.
Executes tasks to the ordinance of the superior or upon his initiative, which are not listed in the job description, but based on the job it is part of his job, or in case of emergency or if it is additional part of his job.

**Responsible for**:
Performing their job in compliance with the guidelines given
Drawing attention to the manager to any difficulties in understanding or following the guidelines
Drawing attention to inefficiency of the system
Take responsibility for those safety aspects identified for the given position

Essential qualifications

Bach. degree in an Engineering field such as electrical, electronic or electromechanics or related fields.
Thorough knowledge in Metrology and different variables such as: Temperature, Flow, Volume, Mass, Pressure. Speed, Time, Viscosity, etc.
Understanding and Knowledge of the quality system standards ISO 13485, ISO 9001 and ISO 17025.
Experience with Microsoft Office package (Word, Excel, PowerPoint, Outlook).
Fluent in both spoken and written English

Preferred qualifications

Knowledge within documentation control.
Ability to read, analyze, interpret, and implement procedures.
Technical degree or certified 3-5 years´ experience in metrology and calibration of different variables.
Qualification experience in laboratory equipment such as Autoclaves, Climate chambers, Control rooms, Cleanrooms etc.
Experience in regulated industries (e.g., medical device industry).

Required knowledge, skills & abilities

Analytical and problem-solving skills.
Detail oriented and able to follow work instructions.
Effective interaction with internal and external customers / suppliers.
Efficient organizing skills.
Proficient decision-making skills.
Proficient negotiation skills.
Proficient lead skills (planning, organizing, delegating).
Communication skills a

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