Quality Engineer/ Specialist

Posted 19 Days Ago
Be an Early Applicant
Arecibo
3-5 Years Experience
Pharmaceutical
The Role
Validation Technical Writing, Protocol Drafting, Review, Deviation Process Documentation, Supervision of engineers and technicians, Problem-solving, Budget development
Summary Generated by Built In

 For Biotechnology services in the Engineering area.
WHAT MAKES YOU A FIT: 
The Technical Part:

  • Bachelor’s degree in Engineering & four (4) years of relevant experience within the Medical Devices or Pharmaceutical industry.
  • Bilingual (Spanish & English).
  • Shift: Administrative and according to business needs. 
  • Experience in:
    • Master Validation Plans and Reports. 
    • Generation and execution of validation protocols (IQ, OQ,PQ).
    • Preventive maintenance, equipment and processes.
    • Assessment and statistical analysis.

The Personality Part:

  • If you seek humanity’s well-being, are oriented to improve collective health while promoting a long-life without pain, then this is a job for you. You can achieve this by applying your interpersonal skills, analytical capacity without losing sight of the effectiveness and quality of your results. If you think you got all this (and more!) then bring it on!

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

  • Validation Technical Writing Protocol Drafting, Review, Execution Deviation Process Documentation
  • Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
  • Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
  • Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
  • Work with manufacturing, process development and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.
  • Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget, and quality constraints.
  • Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

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?


The Company
HQ: Guaynabo, PR
76 Employees
On-site Workplace
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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