For those who want to keep growing, learning, and evolving. We at Kelly^® Engineering hear you, and we’re here for you!
We’re seeking a Project Engineer to work at a premier manufacturing client in Añasco, PR. Sound good?
Take a closer look below. You owe it to yourself to consider this great new opportunity.
Shift: Administrative Shift with availability to support other shifts and weekends/OT as needed 

Why you should apply to be Project Engineer:

• Competitive pay rate with opportunities for overtime
  

• Work with a leading organization in the pharmaceutical, biotechnology, and medical device sector
  

• Gain hands-on experience with CAPEX projects and advanced facility systems
  

• Expand your expertise in regulatory compliance and validation across complex engineering environments

This job might be an outstanding fit if you:

• Have a Bachelor’s degree in Engineering (required)
  

• Have 6+ years of experience in facilities, utilities, and equipment validation in pharmaceutical, biotech, or medical device industries
  

• Possess knowledge of FDA, OSHA, EPA, GMP’s, and ISO requirements
  

• Have experience in facility validation, protocol development, and HIPPA filtration
  

• Demonstrate expertise in Building Automation Computer System Validation, HVAC & Utilities, and Compressed Air Systems (IQ, OQ, PQ Validation)
  

• Are proficient in generating technical documentation and validation protocols
  

• Understand systems architecture and process/technology change implementation
  

• Exhibit strong project management, cost control, and team leadership skills
  

• Are experienced with Organizational Excellence, Lean/Six Sigma methodologies
  

• Are Bilingual (Spanish & English)

What’s a typical day as Project Engineer? You’ll be:

• Planning, developing, and implementing documentation, procedures, and trainings for the engineering team
  

• Participating in the Validation Life Cycle of regulated projects
  

• Generating validation plans, URS, FRS, SDS, traceability matrix, and developing/executing validation protocols (FAT/SAT/IQ/OQ/PQ)
  

• Providing statistical analysis and developing sampling plans
  

• Reviewing and approving validations for computer and automation systems
  

• Troubleshooting computer and automation systems during validation runs
  

• Recommending process and quality improvements
  

• Working with manufacturing/lab equipment, utilities, and facilities
  

• Identifying requirements for computerized operations and ensuring compliance
  

• Analyzing testing results and determining acceptability
  

• Documenting non-conformances/protocol deviations
  

• Managing installation of equipment/software modifications
  

• Assisting with vendor selection, budgeting, procurement, and training
  

• Overseeing validation contractor resources
  

• Generating and reporting metrics for Validation System performance
  

• Preparing information for Quality and Operational Reviews
  

• Collaborating with cross-functional teams
  

• Ensuring regulatory compliance (FDA, ISO, OSHA, EPA)
  

• Participating in external audits and regulatory submissions

Kelly Engineering PR Offers!

• Exposure to a variety of career opportunities as a result of our expansive network of client companies
  

• Career guides, information and tools to help you successfully position yourself throughout every stage of your career
  

• Access to more than 3,000 online training courses through our Kelly Learning Center
  

• Weekly pay (W2)
  

• Vacations, Sick & Holidays paid*
  

• Christmas bonus*

Apply to be Project Engineer today!
Lilly Abouomar, Senior Recruiter 9395454792
#SETTPuertoRico

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