Technical Writer - 171

Posted 3 Days Ago
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Añasco
Junior
Pharmaceutical
The Role
The Technical Writer will create clear and accurate documentation for product development in the Pharmaceutical and Medical Devices industries, ensuring compliance with regulations and collaborating with cross-functional teams to reflect necessary data and changes. Responsibilities include developing SOPs, maintaining documents, and contributing to validation processes.
Summary Generated by Built In

 For Technical Writing services in the Engineering & Manufacturing areas. 

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor's Degree in Life Sciences, Engineering, or a related field and at least two (2) years of previous exposure to Technical Writing activities within the Pharmaceutical or Medical Devices industry. 
  • Bilingual, Spanish and English (good communication)
  • Shift: Administrative & according to business needs 
  • Experience in:
    • SOP Development
    • Validation Documentation Development
    • GMP & GDP 

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 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)

  • Responsible for creating clear, concise, and accurate documentation for product development and technical processes.
  • Collaborating with cross-functional teams, you will ensure that all materials meet quality standards and effectively communicate complex information.
  • Tasked with documenting procedures, manuals, and safety guidelines in compliance with industry regulations.
  • Responsible for maintaining up-to-date documentation to reflect changes in product specifications and regulatory requirements.
  • Work closely with engineers, product managers, and other stakeholders to gather necessary data and provide well-structured documentation.
  • Support the development of new processes or troubleshoot existing ones.
  • Support the validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
  • Coordinates and communicates all testing with affected functional groups and evaluates test results.
  • Support the execution of equipment, facility, and utilities validation studies.
  • Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.

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?

Top Skills

Gdp
Gmp
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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