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 or related discipline and at least five (5) years of experience inQuality Engineering within GMP pharmaceutical or biologics manufacturing environments preferably supporting API (bulk drug substance) operations.
• 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.
  • 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.
  • Microsoft Office and quality systems such as TrackWise Veeva QMS Kneat or similar platforms; experience supporting continuous improvement initiatives is preferred.

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 senior technical resource from the Quality Engineering perspective on projects and team initiatives involving facilities equipment utilities maintenance systems and manufacturing processes.
• Review qualification and commissioning documentation to ensure compliant GMP-ready deliverables.
• Monitor and trend qualified utilities performance against internal specifications and applicable regulatory requirements.
• Escalate utility excursions and support preparation of technical assessments for Quality Engineering review.
• Execute assigned maintenance engineering qualification and quality-related activities.
• Support qualification strategy development and implementation activities.
• Author and progress investigations conducting Root Cause Analysis (RCA) for assigned events and supporting CAPA implementation activities.
• Facilitate problem-solving efforts and participate in risk assessments FMEA activities and quality risk-management initiatives.
• Draft route coordinate and support the implementation of change controls across impacted functional areas.
• Prepare review and maintain audit-defensible technical documentation that complies with Good Documentation Practices (GDP) and data-integrity requirements.
• Communicate significant quality-related issues promptly to Quality Engineering and Quality Management teams.
• Support inspection readiness efforts including regulatory inspections pre-approval inspections (PAI) biologics license application (BLA) inspections and routine GMP audits.
• Participate in self-inspection programs and support remediation activities as required.
• Utilize statistical analysis and process data to identify variability and drive continuous improvement initiatives.
• Collaborate with Engineering Maintenance Operations Validation and Quality teams to ensure compliant execution of activities and timely project completion.
• Operate with minimal supervision while maintaining compliance within assigned authority levels and quality requirements.

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