Sr. Engineer - Manufacturing Equipment & Systems

Flexible & Integrated Technical Services, LLC

Juncos (PR)

Presencial

USD 90.000 - 120.000

Jornada completa

Hace 2 días
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Descripción de la vacante

FITS LLC, a Puerto Rico-based engineering and technical firm, seeks a Senior Engineer to own validation activities for a leading biotechnology manufacturer. You’ll diagnose failures, drive corrective actions, and lead improvements to keep systems reliable and compliant.

Qualifications include a Bachelor’s degree with four years in pharma or regulated industry, shift flexibility, project management, and bilingual English/Spanish.

Formación

  • Bachelor’s degree in engineering with 4+ years in pharma/regulated industries.
  • Shift flexibility: Administrative, and per business needs.
  • Project management experience in regulated environments.
  • Bilingual English and Spanish proficiency.

Responsabilidades

  • Develop and apply engineering techniques and procedures for complex assignments.
  • Create and update engineering policies and procedures impacting multiple units.
  • Supervise and coordinate engineers, associates and technicians on projects.
  • Apply mature engineering knowledge to planning and executing projects.
  • Serve as a technology specialist with responsibility for methodologies in an area.

Conocimientos

Project management
Bilingual English/Spanish
Engineering problem solving

Educación

Bachelor’s degree in Engineering

Herramientas

IBM Maximo

Descripción del empleo

For Validation services in the Engineeringarea.

FITS is looking for a Senior Engineer to support a leading biotechnology manufacturer. You’ll be the technical owner behind critical manufacturing equipment: assessing failures, driving corrective actions, and leading improvements that keep systems reliable and compliant. If you enjoy solving complex equipment problems and owning them through closure, this role is for you.

What Makes You a Fit:
  • Bachelor’s degree plus four (4) years of experience as an Engineer in the pharmaceutical or regulated industry
  • Shift: Administrative, and according to business needs
  • Project management skills
  • Bilingual (English and Spanish)
Preferred Qualifications:
  • Manufacturing equipment support in a regulated pharma/biotech environment
  • System Owner and engineering impact assessments
  • Technical investigations, failure analysis, and CAPA
  • IBM Maximo work order management
  • Preventive maintenance strategies, Job Plans, and SOPs
  • Engineering controls for safety incidents
  • Equipment troubleshooting, obsolescence, and modernization projects
  • Biopharma equipment: centrifuges, autoclaves, process tanks, chromatography, UF/DF, homogenizers, and filter integrity testers
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
  • Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
  • Develop engineering policies and procedures that affect multiple organizational units.
  • Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
  • Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
  • Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
  • Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
  • Application of mature engineering knowledge in planning and conducting projects.
Being a FITS Piece Comes With Perks
  • Work on high-impact projects with one of Puerto Rico’s top pharmaceutical manufacturers
  • Opportunities to grow your career across FITS’ network of clients in pharma, biotech, and medical devices
Who We Are

FITS is a Puerto Rico-based engineering and technical firm. We connect skilled professionals with leading companies in regulated industries, including pharmaceutical, biotech, medical device, and manufacturing. We believe the right talent fits like the right piece, and we work to make every placement a match that lasts.

Are you the next piece?
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