Sr. Engineer - Manufacturing Equipment & Systems

 For Validation services in the Engineering area.

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)

• 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.

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