Quality Engineer

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

About Flexible & Integrated Technical Services, LLC

• 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?

• 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?

Responsibilities

• Quality Systems and computer platforms (e.g., Microsoft Office, TrackWise, Veeva QDocs, QMS, Kneat, GMARS).
• Good Documentation Practices (GDP), data integrity principles, regulatory compliance, and inspection readiness activities.
• 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.

Requirements

• The Technical Part: Bachelor’s 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.
• GMP pharmaceutical or biologics manufacturing environments, including Facilities, Utilities, Maintenance, and Engineering (FUME) systems.
• Commissioning, qualification, validation, and engineering documentation processes.
• Notify the assigned QA Engineer or Quality management of significant quality-related issues in a timely manner.

Preferred

• Investigations, Root Cause Analysis (RCA), CAPA, change control, and risk management methodologies (FMEA preferred)..

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 .