Process Engineer

Posted 11 Days Ago
Be an Early Applicant
Añasco, PRI
In-Office
Mid level
Pharmaceutical
The Role
Lead and execute validation activities for process changes and equipment modifications in pharmaceutical/medical device manufacturing. Manage validation projects, develop process control strategies, prepare validation documentation, coordinate cross-functional teams, provide training, drive process improvements, and ensure compliance with GMP/GDP, safety, and quality requirements while reporting progress to stakeholders.
Summary Generated by Built In

For Engineering services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s degree in Engineering and a minimum of three (3) years of exposure in Validation activities within the Pharmaceutical or Medical Device Industry.
  • Excellent verbal/written communication skills (English and Spanish) 
  • Shift: Administrative & according to business needs 
  • Experience in:
    • Validation Management & Process Improvement 
    • Leading projects, managing timelines, and effectively communicating with stakeholders. 
    • GMP & GDP regulations

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)

  • Lead and execute validation activities for process changes and equipment modifications.
  • Manage validation projects ensuring compliance with regulatory standards and company policies.
  • Drive improvements in existing tooling and redesign workstations to enhance process robustness.
  • Develop and implement process control strategies for manufacturing operations.
  • Prepare and maintain validation documentation, protocols, and reports.
  • Coordinate cross-functional teams to ensure timely completion of validation tasks.
  • Provide training to personnel on validation procedures and document updates.
  • Monitor and report project progress to key stakeholders regularly.
  • Identify opportunities for continuous improvement in validation and process control.
  • Ensure adherence to safety, quality, and regulatory requirements throughout all activities.

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
  • Minimum three (3) years exposure in validation activities within Pharmaceutical or Medical Device industry
  • Excellent verbal and written communication skills in English and Spanish
  • Experience in Validation Management and Process Improvement
  • Experience leading projects, managing timelines, and communicating with stakeholders
  • Knowledge of GMP and GDP regulations
  • Experience preparing and maintaining validation documentation, protocols, and reports
  • Ability to work administrative shift according to business needs
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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