Manufacturing Operation Specialist
About the job
- A Bachelor's degree and five years of experience as a Scientist within the pharmaceutical or regulated industry are required.
- Bilingual proficiency in English and Spanish is required.
- Project management skills are required.
- Experience in manufacturing operations is required.
- Experience creating, reviewing, and approving documents is required.
- Experience working with manufacturing operators is required.
- The work schedule is non-standard and depends on business needs.
- Initiate, revise, and approve manufacturing procedures, ensuring they reflect current operations, and serve as a document owner.
- Assess process performance by observing floor operations and reviewing performance data; evaluate, plan, and implement solutions.
- Provide troubleshooting support.
- Assist in generating training materials and may provide training on scientific or technical aspects of the process.
- Support establishment of process-monitoring parameters and control limits, collect process-monitoring data, and support assessment of deviations.
- Support timely execution of quarterly process-monitoring reports.
- Ensure non-conformances are triaged within the established goal.
- Author investigation reports.
- Execute corrective actions.
- Manage non-conformance and corrective and preventive action closure within the established goal.
- Monitor and communicate incident trends.
- Review equipment and system root-cause analysis investigations and support trend evaluations.
About the company
FITS, LLC provides integrated engineering, compliance, and technical services to pharmaceutical, biotech, medical device, and healthcare organizations in Puerto Rico. It covers commissioning, qualification and validation (CQV), utilities and facilities engineering, maintenance, EHS, automation, and technical staffing to help clients maintain FDA-compliant operations and improve performance of mission-critical systems. Acting as an extension of client operations, FITS delivers turnkey projects, regulatory readiness, quality assurance, and continuous improvement with a multidisciplinary team to support site expansions and ongoing operations. Its goal is to help life-sciences and healthcare facilities scale safely and efficiently while ensuring reliable, compliant operations.
Company Size
51-200
Company Stage
Growth Equity (Non-Venture Capital)
Total Funding
$8M
Headquarters
Aguada, Puerto Rico
Founded
2008
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Simplify's Take
What believers are saying
- FITS posted active 2026 openings in validation, C&Q, project management, and process development.
- Its 2026 jobs span Juncos, Dorado, Yauco, and Juana Díaz, signaling broad demand.
- Federal contractor registration with SAM.gov expands access to government-funded facilities work.
What critics are saying
- FITS depends on contract hiring, exposing revenue to client shutdowns and procurement delays.
- Heavy concentration in Puerto Rico life sciences ties FITS to local plant expansions and slowdowns.
- A rival integrator winning Amgen or J&J accounts would immediately compress FITS utilization.
What makes Flexible & Integrated Technical Services unique
- FITS embeds CQV, utilities, and technical staffing inside Puerto Rico regulated plants.
- Clients include Amgen, Lilly, Bristol Myers Squibb, Abbott, Johnson & Johnson, and CooperVision.
- Founded 2008, FITS combines engineering, maintenance, and validation under one local service platform.
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Benefits
Flexible Work Hours