CSV Engineer - Environmental Monitoring

Azzur Group; Summit (NJ); On-site; USD 62,000 - 84,000; Full time

Job summary

An established industry player is seeking a Computer System Validation Specialist to ensure compliance with regulatory standards in a dynamic environment. This role involves generating validation documentation, coordinating validation phases, and supporting audits. The ideal candidate will have a strong understanding of cGMP and regulatory requirements, along with hands-on experience with environmental monitoring equipment. Join a forward-thinking team dedicated to process improvement and compliance excellence, where your contributions will have a significant impact on the quality of systems used in the pharmaceutical industry.

Qualifications

• Experience in generating validation documentation and performing change control activities.
• In-depth understanding of cGMP and FDA regulatory standards.

Responsibilities

• Generate and review validation documentation to ensure compliance.
• Coordinate validation phases and provide project updates.
• Assist with audits and ensure compliance during inspections.

Skills

Computer System Validation

Regulatory Compliance

Problem-Solving

Project Management

Communication Skills

Education

Bachelor’s degree in Computer Science

Bachelor’s degree in Engineering

Bachelor’s degree in Life Sciences

Tools

Environmental Monitoring Equipment

Particle Counters

Air Samplers

Microbial Monitors

Job description

1 week ago Be among the first 25 applicants

Direct message the job poster from Azzur Group

Leader in GxP Software Validation (CSV) | Compliance | ISPE | ISTQB | QMS

I am seeking an experienced Computer System Validation (CSV) Specialist to support the validation of computer systems and environmental monitoring equipment such as particle counters while ensuring compliance with regulatory requirements. The CSV Specialist will be responsible for generating validation deliverables, supporting audits, driving change controls, and assisting in process improvement activities in an OnSite setting. This role requires in-depth knowledge of cGMP, regulatory standards, and quality systems to ensure robust testing and qualification of systems that are fit for use.

Responsibilities

• Generate and review validation documentation with the site CSV team, ensuring compliance with internal procedures and regulatory standards.
• Identify opportunities to streamline CSV activities, improving efficiency while maintaining compliance
• Coordinate and monitor validation phases, providing regular project updates and ensuring timely execution of activities.
• Create and execute validation test scripts to ensure systems meet cGMP and regulatory requirements.
• Assist with audits, ensuring compliance and providing support for validated systems during internal and regulatory inspections.
• Lead change control processes and investigate issues related to validated systems to ensure compliance is maintained.
• Provide guidance on system upgrades and update operating procedures to meet regulatory requirements
• Review CSV procedures, provide feedback, and participate in meetings to ensure documentation quality.
• Engage in the change control process, assessing changes to validated systems for regulatory compliance.

Qualifications

• Bachelor’s degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences, or related discipline).
• Proven experience in Computer System Validation and regulatory compliance in a highly regulated industry (e.g., pharmaceutical, healthcare).
• Hands-On Experience with environmental monitoring equipment such as Particle Counters, Air Samplers, Microbial Monitors, etc
• In-depth understanding of cGMP, FDA, and other regulatory standards (HPRA, etc.).
• Experience in generating validation documentation (e.g., protocols, qualification reports) and performing change control activities.
• Ability to manage multiple projects and tasks simultaneously in a fast-paced environment.
• Strong problem-solving skills and ability to drive process improvements.
• Excellent communication and interpersonal skills to interact with cross-functional teams and management.
• Experience with audits and supporting audit activities related to computer systems and validation.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Azzur Group by 2x

Get notified about new Environmental Engineer jobs in Summit, NJ.

New York, NY $62,400.00-$83,200.00 1 week ago

New York, NY $80,000.00-$110,000.00 1 month ago

Cranford, NJ $65,000.00-$72,000.00 1 week ago

New York, NY $72,000.00-$84,500.00 3 weeks ago

New York, NY $60,000.00-$75,000.00 3 months ago

South Plainfield, NJ $48.00-$58.00 1 day ago

Early Careers Requisition for Entry Level Candidates

New York, NY $52,000.00-$89,700.00 1 week ago

New York, NY $85,000.00-$120,000.00 1 week ago

New York, NY $39,300.00-$176,567.00 1 year ago

New York, NY $165,000.00-$210,000.00 3 weeks ago

New York, NY $68,000.00-$102,000.00 1 week ago

New York, NY $51,413.00-$62,260.00 1 week ago

Principal Environmental Remediation Engineer

New York, NY $67,757.00-$98,128.00 1 day ago

Morristown, NJ $74,000.00-$80,000.00 2 days ago

Water Resources Engineer/Hydraulic Modeler

Millburn, NJ $100,000.00-$125,000.00 1 month ago

Manhattan, NY $75,000.00-$85,000.00 8 months ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.