Top 307 Validation engineer Jobs in Somerville, Nj

Quality Engineer
Interact Engineering LLC —Whippany, NJ
- $45 an hour
- Temporary
- 5 years
- Mid-level
- Master's degree
Quick Apply
Senior Quality Engineer
NJM Insurance —Ewing, NJ
- $100,402 - $116,574 a year
- Full-time
- Hybrid work
- Computer science
- 7 years
- Computer Science
- Paid parental leave
- Disability insurance
Quick Apply
Financial Analytics Data Engineer
Daiichi Sankyo, Inc. —Basking Ridge, NJ
- $127,280 - $190,920 a year
- Computer Science
- Finance
- Bachelor's degree
13d
Sr Packaging and Product Device Engineer
Zing Recruiting —Somerset, NJ
- $145,000 a year
- 5 years
- Senior level
- Leadership
- Health insurance
- Dental insurance
Quick Apply
L2 Batch Support (Pennington)
Matlen Silver —Pennington, NJ
- $65 - $68 an hour
- Contract
- 5 years
- SQL
- Senior level
- Health insurance
- Dental insurance
Quick Apply
1d
Lead Validation Engineer
Zenith LifeScience —South Plainfield, NJ
- $136,000 a year
- Full-time
- 3 years
- Master's degree
- Databases
Validation Engineer
Zenith LifeScience —South Plainfield, NJ
- $70,000 - $80,000 a year
- Full-time
- 3 years
- Bachelor's degree
- Product management
Computer System Validation Engineer
Katalyst Healthcares & Life Sciences —Princeton, NJ
- Contract
- Hybrid work
- Computer Science
- Mid-level
- Bachelor's degree
Quick Apply
Validation Engineer
Empower Lifescience —Springfield, NJ
- $40 - $65 an hour
- Contract
- Mid-level
- Continuous improvement
- In-person
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2d
Validation Engineer
AM Logic Corporation —Edison, NJ
- Email
- Mid-level
- Bachelor's degree
Validation Engineer II
AbbVie —Branchburg, NJ
- $75,000 - $142,500 a year
- Full-time
- Computer science
- Computer Science
- Engineering
- Paid holidays
- Health insurance
Validation Engineer
Design Group —East Brunswick, NJ
- Full-time
- Background check
- Bachelor of Science
- Pass drug screening
Data Analyst
Helishores —Piscataway, NJ
- $80,850 a year
- Monday to Friday
- Bachelor of Science
- Mid-level
- Office
13d
Software Engineers
Econtenti Inc —Edison, NJ
- Computer Science
- Software troubleshooting
- Office
Process Engineer I
Integra LifeSciences —Plainsboro, NJ
- $62,100 - $85,100 a year
- Email
- Engineering
- English
- Microsoft Office
- Disability insurance
- Health insurance
Sr. Validation Engineer I
AM Logic Corporation —Edison, NJ
- $104,000 - $110,000 a year
- Email
- Databases
- SharePoint
- Senior level
Associate Data Engineer (Remote)
Crum & Forster —Morristown, NJ
- $71,600 - $105,000 a year
- Remote
- Computer science
- Computer Science
- Mid-level
- Employee stock purchase plan
- Health insurance
Associate Process Equipment and Reliability Engineer
WuXi Biologics —Cranbury, NJ
- $55,000 - $88,000 a year
- Evenings as needed
- Ability to walk for extended periods
- Ability to lift 50 pounds
- Analysis skills
Software Engineer
Optum —Basking Ridge, NJ
- $72,800 - $130,000 a year
- Full-time
- Azure
- Pass drug screening
- Mid-level
- AD&D insurance
- Employee stock purchase plan
7h
GxP Lab Computing Analyst
Zifo —Mount Olive, NJ
- $75,000 - $80,000 a year
- Full-time
- Hybrid work
- Computer science
- Computer Science
- Bachelor of Science
- Health insurance
- Dental insurance
Quick Apply
13d

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validation engineer jobs near somerville, nj

Quality Engineer

Interact Engineering LLC
Whippany, NJ

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Job Details

Temporary | Full-time
$45 an hour

Qualifications

Chemical Engineering
Drug regulation
Master's degree
Manufacturing facility experience
Bachelor's degree
Medical device manufacturing facility experience
Pharmaceutical company experience
Cleanroom experience
Biomedical regulatory compliance
Root cause analysis
ISO 13485
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

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 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.

Pay: $45.00 per hour

Work Location: In person

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Refine Your Search

validation engineer jobs in somerville, nj

Quality Engineer

Senior Quality Engineer

Financial Analytics Data Engineer

Sr Packaging and Product Device Engineer

L2 Batch Support (Pennington)

Lead Validation Engineer

Validation Engineer

Computer System Validation Engineer

Validation Engineer

Validation Engineer

Validation Engineer II

Validation Engineer

Data Analyst

Software Engineers

Process Engineer I

Sr. Validation Engineer I

Associate Data Engineer (Remote)

Associate Process Equipment and Reliability Engineer

Software Engineer

GxP Lab Computing Analyst

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