For Automation services in the Manufacturing and Engineering area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors degree in Engineering (Electrical Chemical Computer Mechanical Industrial) and at least three (3) years of experience in Automation and Validation activities within the Medical Device or Pharmaceutical industry.
- Bilingual: Spanish and English (verbal/ written)
- Shift: Administrative and according to business needs.
- Experience in:
- DeltaV PLC and Instrumentation
- Computer systems validation experience in regulated operations (preferably GMP operations)
The Personality Part:
AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)
- Oversee the development and revision of software and hardware requirements and design documentation.
- Perform software and hardware testing including customer reviews source code checks and unit integration system and platform-level tests.
- Install or coordinate installation of automation control hardware and software including vendor engagement.
- Manage and troubleshoot control system problems provide solutions and implement actions.
- Provide technical support to the automation technicians in field and software interventions.
- Identify customer requirements and address concerns related to both new and existing control systems.
- Monitor analyze and define action plans to reduce control system situations and/or interventions.
- Perform analysis to identify trends. Understand data trends and proactively get involve and/or support discussion and action plans.
- Evaluate automation code or systems to prevent safety environmental or quality risks product loss or unplanned downtime.
- Conduct and lead investigations while proactively assessing events to prevent interventions and eliminate recurrence.
- Initiate and implement change controls to optimize the systems or processes including business case technical recommendations and resources/cost estimates.
- Develop review and/or approve Computer System Validation (CSV) documentation.
- Prepare AQMS reports and perform audit trail evaluations.
- Follow policies and procedures to maintain the validation state of the control systems.
- Participate actively in meetings and huddle board discussions.
- Maintain process team and/or supporting areas informed of activities and status as applicable.
- Promptly identify any roadblocks and communicate them to the relevant stakeholders in a timely manner.
- Represent the Automation area by sharing priorities strategies schedules and project updates to team members.
- Ability to connect how equipment control system and process changes will affect automation and vice versa.
- Understand and actively support the delivery of key site strategic initiatives.
- Demonstrate proficiency in area control strategies and actively monitor key operational parameters within the assigned area (Quality & EHS). Ensure compliance with all relevant internal and external Computer Systems Quality policies procedures and regulations applicable to the supported automation systems.
- Ensure compliance with Environmental Health and Safety regulations and internal programs.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves onhow we treat the most important piece of our companys puzzle: you! We integrate Engineering Construction Maintenance Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible family-oriented and focused on our resources well-being while providing our Pharmaceutical Medical Device and Manufacturing industryclients with top-notch quality talent.Were FITS!
Are you the Next Piece
Required Experience:
Senior IC
For Automation services in the Manufacturing and Engineering area. WHAT MAKES YOU A FIT:The Technical Part:Bachelors degree in Engineering (Electrical Chemical Computer Mechanical Industrial) and at least three (3) years of experience in Automation and Validation activities within the Medical Device...
For Automation services in the Manufacturing and Engineering area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors degree in Engineering (Electrical Chemical Computer Mechanical Industrial) and at least three (3) years of experience in Automation and Validation activities within the Medical Device or Pharmaceutical industry.
- Bilingual: Spanish and English (verbal/ written)
- Shift: Administrative and according to business needs.
- Experience in:
- DeltaV PLC and Instrumentation
- Computer systems validation experience in regulated operations (preferably GMP operations)
The Personality Part:
AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)
- Oversee the development and revision of software and hardware requirements and design documentation.
- Perform software and hardware testing including customer reviews source code checks and unit integration system and platform-level tests.
- Install or coordinate installation of automation control hardware and software including vendor engagement.
- Manage and troubleshoot control system problems provide solutions and implement actions.
- Provide technical support to the automation technicians in field and software interventions.
- Identify customer requirements and address concerns related to both new and existing control systems.
- Monitor analyze and define action plans to reduce control system situations and/or interventions.
- Perform analysis to identify trends. Understand data trends and proactively get involve and/or support discussion and action plans.
- Evaluate automation code or systems to prevent safety environmental or quality risks product loss or unplanned downtime.
- Conduct and lead investigations while proactively assessing events to prevent interventions and eliminate recurrence.
- Initiate and implement change controls to optimize the systems or processes including business case technical recommendations and resources/cost estimates.
- Develop review and/or approve Computer System Validation (CSV) documentation.
- Prepare AQMS reports and perform audit trail evaluations.
- Follow policies and procedures to maintain the validation state of the control systems.
- Participate actively in meetings and huddle board discussions.
- Maintain process team and/or supporting areas informed of activities and status as applicable.
- Promptly identify any roadblocks and communicate them to the relevant stakeholders in a timely manner.
- Represent the Automation area by sharing priorities strategies schedules and project updates to team members.
- Ability to connect how equipment control system and process changes will affect automation and vice versa.
- Understand and actively support the delivery of key site strategic initiatives.
- Demonstrate proficiency in area control strategies and actively monitor key operational parameters within the assigned area (Quality & EHS). Ensure compliance with all relevant internal and external Computer Systems Quality policies procedures and regulations applicable to the supported automation systems.
- Ensure compliance with Environmental Health and Safety regulations and internal programs.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves onhow we treat the most important piece of our companys puzzle: you! We integrate Engineering Construction Maintenance Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible family-oriented and focused on our resources well-being while providing our Pharmaceutical Medical Device and Manufacturing industryclients with top-notch quality talent.Were FITS!
Are you the Next Piece
Required Experience:
Senior IC
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