Automation Engineer

Posted 24 Days Ago
Be an Early Applicant
Carolina
In-Office
3-3 Annually
Mid level
Pharmaceutical
The Role
The Automation Engineer will oversee automation and validation in manufacturing, address control system issues, and ensure compliance with quality standards. Responsibilities include software and hardware testing and customer support.
Summary Generated by Built In

For Automation services in the Manufacturing and Engineering area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s 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:    

  • Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

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 on how we treat the most important piece of our company's 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 industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?

Top Skills

Automation Control Hardware And Software
Computer Systems Validation
Deltav
Plc
Am I A Good Fit?
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The Company
HQ: Guaynabo, PR
76 Employees
Year Founded: 2008

What We Do

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's 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 industry clients with top-notch quality talent. We're FITS!

Are We The Right Piece For You?
We are:

Experienced and knowledgeable in the Industry
Committed to Safety
Always compliant with FDA Regulations & Audits
Cost Effective
Proven successful track record
Over ten (10) years of experience

If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]

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