Biotech Validation Engineer - Aseptic Filling (Bilingual)

Veg Group; Barceloneta (PR); Vor Ort; USD 70.000 - 100.000; Vollzeit

Zusammenfassung

A leading engineering services provider in Puerto Rico is seeking a Validation Engineer with hands-on experience in biotech/pharmaceutical manufacturing. The candidate will be responsible for executing and supporting validation activities for equipment and processes to meet regulatory requirements. A bachelor's degree is required along with 3–7+ years of validation experience. Strong skills in aseptic processing, vial filling operations, and regulatory guidance are essential. The role demands bilingual proficiency in English and Spanish and offers an opportunity to shape the future of healthcare and technology.

Qualifikationen

• 3–7+ years of validation experience in biotech or pharmaceutical industry.
• Strong knowledge in cGxP and regulatory guidance.
• Experience in Design Documentation (URS, DS) and IQ, OQ, PQ protocols.

Aufgaben

• Develop, review, and execute validation protocols including IQ, OQ, PQ.
• Perform process validation activities related to sterile manufacturing.
• Ensure compliance with cGMP, FDA, EMA, and ICH guidelines.
• Support commissioning and qualification activities for new equipment.

Kenntnisse

Aseptic processing

Vial filling operations

Sterile manufacturing environments

Bilingual (English / Spanish)

MS Windows and Microsoft Office

Regulatory compliance

Ausbildung

Bachelor’s degree in Engineering, Chemistry, Biology, or related field

Jobbeschreibung

A leading engineering services provider in Puerto Rico is seeking a Validation Engineer with hands-on experience in biotech/pharmaceutical manufacturing. The candidate will be responsible for executing and supporting validation activities for equipment and processes to meet regulatory requirements. A bachelor's degree is required along with 3–7+ years of validation experience. Strong skills in aseptic processing, vial filling operations, and regulatory guidance are essential. The role demands bilingual proficiency in English and Spanish and offers an opportunity to shape the future of healthcare and technology.