Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide.

Currently, one of our clients in the Medical Device sector is looking to hire a Project Manager in Dorado, Puerto Rico.

Requirements:

Bachelor’s degree, with 5 - 10 years of relevant experience.
Program Management Professional (PMP) Certification, preferred.
Develop project plans, including scope, planning, execution, control, and close-out activities, schedules, and budgets.
Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), and ISO 13485.
Experience supporting new product introductions (NPI/NPD), including process development, equipment qualification, and process validation.
Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems.
Excellent communication and leadership abilities in Spanish & English, required

This position does not offer visa sponsorship. Applicants must be fluent in both Spanish and English. Please do not apply if you do not meet these requirements.

Job Types: Full-time, Contract

Education:

Bachelor's (Required)

Experience:

Project Manager: 5 years (Required)
NPI: 5 years (Required)
Medical Device: 5 years (Required)

Language:

Spanish and English (Required)

Work Location: In person

Pharma-Bio Serv

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