OVERVIEW

The Quality Engineer will support the aseptic manufacturing and quality systems for sterile drug products packaged in glass vials and prefilled syringes. This role ensures compliance with applicable regulatory requirements including

US FDA 21 CFR

Parts 210, 211, 820, EU GMP Annex 1, and

ISO 13485.

The position is responsible for the Quality support functions associated with the manufacturing and packaging of aseptic fill products like Syringes, vials and Cartridges. The position is responsible for the timely assessment of Quality documents associated with the production and packaging of aseptic fill products. This position will also manage projects associated with process, documentation and other improvements necessary in the Quality arena. This role is 100% on site in Whippany, NJ.

ESSENTIAL FUNCTIONS

Key Responsibilities:

1. Quality Systems & Compliance o Ensure compliance with cGMP, Quality System Regulations (QSR), and

ISO 13485

requirements in aseptic manufacturing and packaging. o Support the implementation and continuous improvement of quality systems: CAPA, deviations, change control, risk management, and supplier qualification. o Author, review, and approve SOPs, protocols, batch records, and validation documents. o Maintain compliance with

FDA 21 CFR

Part 210/211 (drug manufacturing), Part 820 (device QSR), and EU Annex 1 sterile manufacturing requirements. 2. Aseptic Manufacturing Oversight o Provide on-floor quality support for aseptic filling operations of glass vials and prefilled syringes. o Perform aseptic technique observation, media fill support, and personnel qualification oversight. o Review and assess cleanroom classification, environmental monitoring, and process simulations. o Verify compliance of gowning, cleaning, and disinfection practices per EU Annex 1 and FDA expectations. 3. Process & Equipment Support o Support validation and qualification of aseptic filling lines, isolators, RABS, cleanrooms, utilities, and associated equipment. o Participate in FAT, SAT, IQ/OQ/PQ and technical transfers for sterile manufacturing lines. o Ensure equipment, packaging, and container-closure systems for glass vials and prefilled syringes meet USP <1207> container closure integrity testing (CCIT) requirements. o Conduct risk assessments (FMEA, HACCP, risk-based approach per

ICH Q9/Q10

). 4. Investigations & Continuous Improvement o Lead and support root cause investigations for deviations, OOS/OOT, and complaints related to aseptic operations and packaging. o Develop and track CAPAs to ensure timely and effective implementation. o Monitor process performance and quality trends to identify opportunities for improvement. o Drive implementation of quality by design (QbD) and continuous improvement initiatives in aseptic processes. 5. Documentation & Regulatory Support o Ensure accurate, complete, and contemporaneous documentation in compliance with data integrity principles (ALCOA+). o Support preparation for regulatory inspections (FDA, EMA, Notified Body, MHRA, etc.). o Assist in responding to inspection findings and regulatory queries. o Prepare quality reports, metrics, and risk assessments for management review. 6.

Continuous Improvement:

o Drive continuous improvement initiatives through lean manufacturing principles and Six Sigma methodologies. o Lead quality improvement projects, collaborating with teams to enhance product quality, reduce waste, and improve operational efficiency.

POSITION QUALIFICATIONS EDUCATION/EXPERIENCE

• Bachelor's or master's degree in pharmacy, Microbiology, Biotechnology, Chemical Engineering, or related Life Sciences/Engineering field.
• 5+ years of experience in aseptic pharmaceutical or medical device manufacturing, with direct involvement in glass vial and/or prefilled syringe filling operations.
• Strong understanding of c

GMP, 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.

Skills & Competencies:

o Strong knowledge of aseptic techniques, sterile barrier systems, and contamination control strategies. o Familiarity with quality risk management, statistical data analysis, and process capability tools. o Excellent technical writing and communication skills. o Strong problem-solving and root cause analysis skills. o Ability to work in a dynamic, fast paced, and highly regulated environment.

Physical Requirements:

o Primarily site-based with routine presence in classified cleanroom environments. o Ability to stand for up to 8 hours per day. Frequent sitting, standing, walking, reading written documents and use of computer monitor screen, talking, writing, listening o May require gowning certification for Grade A/B aseptic areas. o Occasional travel for supplier audits, training, or regulatory inspections.

Pay:

$50.00 per hour

Work Location:

In person