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Quality Engineer

Synerfac Technical Staffing

Whippany, NJ

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JOB DETAILS
SKILLS
Asepsis, Assembly Line, Biology, Biotech and Pharmaceutical, Change Control, Chemical Engineering, Cleanroom, Code of Federal Regulations, Continuous Improvement, Contract Manufacturing, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Documentation, Dosage Forms, Drug Manufacturing, Drug Products, Environmental Monitoring, FDA (Food and Drug Administration), FDA Requirements, Failure Mode and Effects Analysis (FMEA), GMP (Good Manufacturing Practices), ICH Regulations, ISO (International Organization for Standardization), Lean Manufacturing, Maintain Compliance, Manufacturing, Manufacturing Requirements, Manufacturing Systems, Medical Equipment, Microbiology, Operational Improvement, Operational Strategy, Performance Analysis, Pharmacy, Process Improvement, Process Validation, Product Positioning, Project/Program Management, Quality Engineering, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Reporting Skills, Risk, Risk Analysis, Risk Management, Root Cause Analysis, Six Sigma, Standard Operating Procedures (SOP), Support Documentation, Time Management, Trend Analysis, Validation Documentation, Writing Skills
LOCATION
Whippany, NJ
POSTED
5 days ago
Out client is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. They have a long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada.

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.






EDUCATION/EXPERIENCE:
Must have a 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.
Must have at least 5 years as a Quality Engineer in a pharmaceutical environment.

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Synerfac Technical Staffing