Sr. Quality Engineer

For Senior Quality Engineering Specialist services in the Quality Assurance / QA Engineering (FUME: Facilities Utilities Maintenance & Engineering) area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelors degree in Engineering (Chemical Biotechnical Biomedical or Mechanical)and at least five (5) years of experience in automated bulk pharmaceutical GMP operations (Production Engineering QA or Technical Services) with understanding of facilities utilities maintenance commissioning & qualification and quality systems.
• Bilingual: Spanish and English (verbal/ written)
• Availability to support a 24/7 operation including irregular hours shift rotations weekends holidays and emergency situations according to business needs.
• Experience in:
  • GMP pharmaceutical or biologics manufacturing environments including Facilities Utilities Maintenance and Engineering (FUME) systems.
  • Quality Systems and computer platforms (e.g. Microsoft Office TrackWise Veeva QDocs QMS Kneat GMARS).
  • Commissioning qualification validation and engineering documentation processes.
  • Investigations Root Cause Analysis (RCA) CAPA change control and risk management methodologies (FMEA preferred)..
  • Good Documentation Practices (GDP) data integrity principles regulatory compliance and inspection readiness activities.

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family especially our resources clients and team other words being a customer service pro is one your (many) talents. Being the Piece means youre 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)

• Serve as a technical resource for initiatives and projects related to assets (equipment/facilities) utilities and processes to support compliant deliverables.
• Support monitoring of qualified utilities performance against internal and external quality requirements and regulations.
• Support execution of maintenance engineering and qualification activities and strategies.
• Support event investigations and participate in Root Cause Analysis led by QA Engineers.
• Support problem solving and risk management activities.
• Support change controls development and implementation.
• Ensure assigned documentation has good technical writing and complies with Good Documentation Practices (GDP) and data integrity requirements.
• Notify the assigned QA Engineer or Quality management of significant quality-related issues in a timely manner.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys 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 industryclients with top-notch quality talent.Were FITS!

Are you the Next Piece