Full-Time
Commissioning and Qualification Lead
Flexible & Integrated Technical Services
51-200 employees
Integrated CQV, compliance, and engineering services.
No salary listed
Pennsylvania, USA
In Person
Bachelor's
 Biology & Biotech (1) |
|---|
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- A Bachelor's Degree in Life Science or Engineering.
- Previous exposure to the validation life cycle within the pharmaceutical industry.
- Bilingual proficiency in Spanish and English.
- Ability to work the administrative shift and adjust according to business needs.
- Skills in writing general documentation in English and using Microsoft Office applications.
- Experience with process commissioning and qualification.
- Experience coordinating validation activities.
- Experience developing change controls.
- Knowledge of current Good Manufacturing Practices and data integrity regulations and guidelines.
- Develop an overall commissioning and qualification plan in conjunction with the client project scheduler and meet key project milestones.
- Lead weekly multidisciplinary commissioning, qualification, validation, engineering, construction management, and user coordination meetings; maintain the organization chart and resource plan.
- Manage health, safety, and environment activities and safe start-up, including lockout/tagout.
- Prepare commissioning, qualification, and validation documentation and execution-readiness materials.
- Execute commissioning, qualification, and validation activities, including P&ID walkdowns and punch-item categorization.
- Manage deviations and change control for process and automation activities.
- Manage punch lists and vendors.
- Develop and review commissioning and qualification test plans and specifications before approval.
- Develop and maintain training materials, matrices, and files for personnel involved in commissioning, qualification, and validation activities, including integrators, computer system validation providers, vendors, and client users.
- Manage and file commissioning, qualification, and validation documentation.
- Manage compliance with system- and area-level schedules and planned resource levels.
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
- Its August 7, 2026 career page still lists open Pennsylvania pharmaceutical hiring.
- Indeed postings in July 2026 show demand for process, quality, automation, and project roles.
- Broad 2026 openings across Juncos, Humacao, Gurabo, and Guayama signal active execution.
What critics are saying
- A Puerto Rico government contract ended August 4, 2026, creating renewal exposure.
- Openings in Juncos, Humacao, and Añasco tie revenue to client site demand.
- If Amgen or another anchor client in-sources engineering, FITS loses a large operating base.
What makes Flexible & Integrated Technical Services unique
- FITS, founded 2008, sells integrated CQV, utilities, and staffing across Puerto Rico.
- Its 2026 website lists Amgen, Lilly, BMS, Abbott, J&J, and CooperVision customers.
- Certified minority, women-owned, and critical supplier status supports regulated-site vendor access.
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Benefits
Flexible Work Hours