CSV Engineer

Inc. (Vti); New York (NY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

A leading global organization in commissioning and validation services is seeking a CSV Engineer for a 2+ month contract in the New York area. This role involves authoring validation documentation and providing guidance on compliance requirements. Candidates should have a BSc in Science or Engineering and significant experience in the biopharmaceutical or medical device sectors. The position offers a mix of onsite and remote work, along with competitive compensation and benefits.

Benefits

Professional Development

Training

Competitive Compensation

Excellent Benefits

Matching 401K

Qualifications

• 5+ years of Biopharmaceutical or Medical Device CSV experience required.
• Hands-on experience with validating BarTender software preferred.

Responsibilities

• Author and execute validation lifecycle documentation.
• Provide guidance in support of system testing requirements.
• Take ownership of related tasks with minimal supervision.

Skills

Communication

Technical Writing

Data Integrity

GAMP

Education

BSc in Science or Engineering

Tools

BarTender

Job description

VTI Life Sciences (VTI)

is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry.

We are currently seeking a CSV Engineer for a 2+ month contract to work on a Class 1 Medical Device Packaging Labeling System validation project for our client in the New York Metropolitan area. This role will be approximately 50% onsite and 50% remote.

Job Responsibilities:

1. Author and execute validation lifecycle documentation, including Validation Plans/Summaries, User Requirements, Functional/Design Configuration Specifications, Trace Matrix, Risk Assessments, Qualification Protocols (IQ/OQ/PQ), and Test Scripts.
2. Assist system users with defining and documenting system use in user, admin, and maintenance SOPs.
3. Provide guidance and coaching in support of system testing requirements based on GAMP principles and 21 CFR, Part 11, Annex 11 compliance, and ISO 13485.
4. Take ownership of related tasks, work under minimal supervision, utilize industry experience and judgment to make decisions, stay proactive, etc.

Job Qualifications:

• BSc in Science or Engineering is required.
• 5+ years of Biopharmaceutical or Medical Device CSV experience is required.
• Specific hands-on experience with validating BarTender (Medical Device) labeling software is preferred.
• Understanding of Data Integrity and GAMP concepts is required.
• Excellent communication and technical writing skills are required.
• Local candidates in the New York City area are preferred.

VTI Life Sciences strives to maintain and inspire professional excellence by providing commissioning, qualification, quality engineering, automation, and validation services to the pharmaceutical, biotechnology, biologics, and medical device industries.

We offer professional development, training, competitive compensation, excellent benefits, a matching 401K, and a stimulating, collaborative work environment. Our commitment is to provide exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm, and diligence.

As a leading global organization in commissioning, qualification, and validation services, VTI continually seeks innovative, talented, and experienced validation professionals for our multinational and global offices. We offer some of the industry’s best salary and benefit packages for our full-time/permanent employees. www.validation.org