Sterile Validation Engineer | GMP Equipment & Systems

RXinsider LTD.; Town of Brookhaven (NY); On-site; USD 82,000 - 110,000; Full time

Job summary

Amneal is seeking a Validation Engineer, Sterile, to support validation activities for manufacturing and packaging equipment, facilities, utilities, and systems in a sterile GMP environment. You will prepare and execute FAT/SAT, IQ/OQ, PQ, and requalification protocols, while ensuring documentation meets cGMP standards and site procedures.

Collaboration with Engineering, Manufacturing, and Quality is essential.

Qualifications

• Bachelor's degree in engineering, life sciences, pharmaceutical sciences, or related field.
• Master's degree preferred.
• 2+ years in Validation/qualification in a GMP‑regulated pharmaceutical, biotechnology, or life‑sciences environment.
• 2+ years in sterile or aseptic environment.
• Working knowledge of cGMP, GDP, FDA regulations, and risk‑based validation principles.
• Strong writing, analytical, and communication skills.

Responsibilities

• Prepare and revise validation plans, protocols, reports, and risk assessments for equipment and systems.
• Execute FAT/SAT, IQ/OQ/PQ, and requalification; document deviations and support investigations.
• Coordinate test execution with Engineering, Manufacturing, Quality, vendors, and contractors.
• Draft/revise SOPs and work instructions; participate in CAPA investigations and effectiveness verification.
• Maintain traceable validation records per cGMP and GDP, support audits.

Skills

cGMP knowledge

GDP knowledge

FDA regulations

risk-based validation

problem-solving

organizational skills

technical writing

effective communication

Education

Bachelor's degree in engineering or life sciences

Master's degree preferred

Tools

Microsoft Office

Electronic quality/validation systems

Job description

Amneal is seeking a Validation Engineer, Sterile, to support validation activities for manufacturing and packaging equipment, facilities, utilities, and systems in a sterile GMP environment. You will prepare and execute FAT/SAT, IQ/OQ, PQ, and requalification protocols, while ensuring documentation meets cGMP standards and site procedures.

Collaboration with Engineering, Manufacturing, and Quality is essential.