Validation Engineer, CSV - SOKOL GxP Services

JOB DESCRIPTION:

The Mid-Level Validation Engineer, CSV is responsible for supporting the successful implementation of manufacturing and laboratory equipment, as well as computerized systems at a multi-use site. This involves interacting with both internal customers and external service providers. In this role, the individual contributes to achieving milestones associated with equipment qualification and systems validation. With minimal supervision and general instructions, the Mid-Level Validation Engineer, CSV performs routine tasks and uses basic analytical skills to identify and solve common problems of limited scope. As a developing team player, the incumbent collaborates with their immediate supervisor and colleagues within their work group to achieve team goals while also building trust and collaborative relationships outside the immediate organization. We currently have three openings in this role.

DUTIES AND RESPONSIBILITIES:

Ensure qualified and validated equipment and systems comply with company policies, guidelines, and procedures.

Develop protocols and reports while following a structured change management process.

Execute equipment qualification and validation protocols, supporting calibration and validation activities.

Supervise vendors performing qualification functions to ensure compliance.

Configure and document computerized systems, managing their lifecycle and validation.

Create validation documents, including Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.

Oversee projects of varying scope, particularly those related to laboratory and manufacturing equipment.

Lead equipment implementation projects, handling scheduling, procurement, site preparation, installation, qualification, and turnover.

Independently manage qualification and full Computerized System Validation (CSV) for single and multi-user systems.

Support internal teams with equipment procurement, calibration, preventive maintenance, and lifecycle needs.

Complete all qualification and validation documentation with precision, meeting company standards.

Provide responsive customer service, addressing qualification and support requests promptly.

Offer technical support and guidance on calibration and equipment qualification matters.

Maintain strong client relationships and foster a positive team environment.

EDUCATION:

• Bachelor’s degree in engineering, computer science, or a related field (required).

QUALIFICATIONS:

• Minimum of 5 years in an FDA-regulated industry, with at least 3 years in Computerized System Validation (CSV).
• Experience working with QC analytical equipment (e.g., plate readers, cell counters, flow cytometers) is a plus.
• Knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work effectively in a team environment and collaborate with cross-functional teams.
• Strong knowledge of cGXP, 21 CFR Part 11, ISPE guidelines, and good documentation practices.
• Skilled in equipment qualification, user requirements documentation, and report writing.
• Excellent analytical, problem-solving, and communication skills.
• Team player, able to collaborate with Engineering, QC, and QA.

WORKING CONDITIONS:

This role may involve working in an office, laboratory, or manufacturing area.

Must be able to work in gowning attire within a controlled environment for extended periods.

Must demonstrate the ability to work safely with hazardous, radioactive, and biological materials and waste, ensuring safety both when working independently and with others.

Must be able to lift up to 15 pounds as needed.

What We Offer:

Join SOKOL GxP Services! We partner with top pharmaceutical and biotech companies to deliver exceptional CxP and compliance services. At SOKOL, we’re dedicated to fostering diversity, supporting local talent, and building strong community connections to connect the best-qualified candidates with our clients. Be part of a dynamic team where you can shape the future of life sciences and advance your career in a collaborative, innovative environment. Our culture promotes growth and inclusivity, with a commitment to professional development and competitive benefits, including:

Health benefits

• PTO
• Holiday pay
• Volunteer hours
• Relocation assistance*
• 401K** program
• Professional development opportunities
• Employee referral program

*Relocation support will be determined on a case-by-case basis.

**Our 401K program is set to launch in the 2025 fiscal year.

How to Apply:

https://www.sokolservices.com/open-positions

All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the from the date of receipt.

By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.

Equal Opportunity Employer Statement:

SOKOL GxP Services is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or any other characteristic protected by law.