Aseptic Quality Engineer – Onsite (Whippany, NJ)

Synerfac Technical Staffing; Whippany (NJ); On-site; USD 104,000 - 146,000; Full time

Job summary

The Quality Engineer will support aseptic manufacturing and quality systems for sterile drug products packaged in glass vials and prefilled syringes. This on-site role at Whippany, NJ requires compliance with FDA, EU, and ISO standards and involves CAPA, deviations, and risk management.

Responsibilities include on-floor quality support, validation and qualification activities, investigations for deviations, and regulatory readiness.

Qualifications

• Bachelor's or master's degree in pharmacy, Microbiology, Biotechnology, Chemical Engineering, or related Life Sciences/Engineering field.
• 5+ years of aseptic pharmaceutical or medical device manufacturing, with direct involvement in glass vial and/or prefilled syringe filling operations.
• Strong understanding of cGMP, FDA 21 CFR Parts 210/211/820, EU Annex 1, ISO 13485.
• Experience with validation, aseptic process simulations, cleanroom classification, and CCIT.
• Prior exposure to combination product regulations is highly desirable.

Responsibilities

• Ensure cGMP, Quality System Regulations (QSR), and ISO 13485 requirements in aseptic manufacturing and packaging.
• Support the implementation and continuous improvement of quality systems: CAPA, deviations, change control, risk management, and supplier qualification.
• Author, review, and approve SOPs, protocols, batch records, and validation documents.
• Provide on-floor quality support for aseptic filling operations of glass vials and prefilled syringes.
• Lead investigations for deviations, OOS/OOT, and complaints related to aseptic operations and packaging.
• Develop and track CAPAs to ensure timely and effective implementation.
• Monitor process performance and quality trends to identify opportunities for improvement.
• Drive implementation of quality by design (QbD) and continuous improvement initiatives.

Skills

Aseptic techniques

Risk management

Data analysis

Technical writing

Root cause analysis

Education

Bachelor's or Master's in Life Sciences/Engineering

Tools

CCIT

FAT/SAT

IQ/OQ/PQ

Job description

The Quality Engineer will support aseptic manufacturing and quality systems for sterile drug products packaged in glass vials and prefilled syringes. This on-site role at Whippany, NJ requires compliance with FDA, EU, and ISO standards and involves CAPA, deviations, and risk management.

Responsibilities include on-floor quality support, validation and qualification activities, investigations for deviations, and regulatory readiness.