Process Engineer (pFMEA)

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.

We are looking for candidates with experience in medical device sector in Risk Assessment (pFMEA) / Process Engineer in Puerto Rico.

Requirement:

• Bachelor’s degree in Engineering.
• 5+ years of hands‐on experience developing, reviewing, or updating Process Failure Mode and Effects Analysis (PFMEA) documentation within regulated industries (medical devices preferred).
• Knowledge of Failure Mode and Effects Analysis (FMEA) methodologies and risk management principles.
• Ability to work independently and manage multiple priorities.
• Knowledge of quality systems and continuous improvement practices.
• Experience supporting manufacturing or process engineering functions.
• Excellent communication skills in English and Spanish, required

Please note: This position does not offer visa sponsorship. Applicants must be fluent in both Spanish and English. Kindly refrain from applying if you do not meet these requirements. We do not provide H1B Visa support / No C2C available.

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 more than 30 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.