Our client is a Pharmaceutical is a technology-focused contract development and manufacturing
organization (CDMO) specializing in solid, semi-solid, and liquid dosage forms, with differentiated
expertise in controlled substances manufacturing. With facilities in the United States and Canada,
supports leading pharmaceutical companies through high-quality manufacturing,
operational excellence, and customer-focused solutions.
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.
Pay $50.00 - $70.00
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 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.
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.
By applying for this job, you agree to receive calls, Al-generated calls, text messages, or emails from Synerfac Technical Staffing and our contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undeliverable messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at www.synerfac.com/privacy/