Process Engineer

Posted 7 Days Ago
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Carolina, PRI
In-Office
Senior level
Pharmaceutical
The Role
Support process engineering for pharmaceutical and medical device clients: evaluate and recommend equipment, contribute to design and procurement, lead verification and Kneat test execution, oversee field implementation, manage CAPA and change control activities, and perform root cause analysis and FMEAs while tracking status and approvals.
Summary Generated by Built In

Process Engineering Services.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering and at least five (5) years of experience within the pharmaceutical or medical devices industry.
  • Bilingual: English and Spanish.
  • Soft Skills: Great attitude and strong desire to learn new skills.
  • Shift: Administrative, and according to business needs
  • Experience in: 
    • Design and installation of new equipment
    • Asset Delivery (C&Q) processes
    • Kneat application preferred.
    • CAPAs and actions implementation.
    • Investigations and problem-solving activities such as root cause analysis, FMEA, and problem analysis.

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 Be The Piece?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

  • Evaluate equipment requiring recapitalization and/or BCP planning and provide implementation recommendations.
  • Develop required documentation to support capital funding requests, as applicable.
  • Provide technical input during design and equipment procurement activities, including review of datasheets, design drawings, etc.
  • Incorporate EHS considerations into proposals, design, and implementation.
  • Support the development and execution of verification activities within the asset delivery scope, including user requirements, design reviews, verification strategy, and Kneat test case execution.
  • Provide technical oversight during field implementation activities.
  • Support the implementation of CAPAs and actions, including procedure updates, engineering documentation revisions, equipment replacements, assessment execution and documentation, and change control generation, among others.
  • Provide technical input and documentation support for problem-solving activities, including root cause analysis, problem analysis, and FMEAs.
  • Provide status updates to process teams and Process Engineering representatives, track ongoing activities, escalate identified issues, and follow up on required approvals.

WHO WE ARE:

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 you the Next Piece?

Skills Required

  • Bachelor's Degree in Engineering
  • At least five (5) years of experience within the pharmaceutical or medical devices industry
  • Bilingual: English and Spanish
  • Experience in design and installation of new equipment
  • Experience with Asset Delivery (C&Q) processes
  • Kneat application experience
  • Experience implementing CAPAs and associated actions
  • Experience with investigations and problem-solving (root cause analysis, FMEA, problem analysis)
  • Strong attitude and desire to learn (soft skills/customer service orientation)
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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