Validation Engineer

Tentative Start Date: March2025

Work authorization: Applicants must have the legal right to work in the United States without requiring sponsorship. Corp-to-Corp (C2C) arrangements are not accepted.

JOB DESCRIPTION:

The CQV Engineer Mid-Level is responsible for supporting the successful commissioning and qualification of classified facilities, critical utilities, manufacturing and laboratory equipment 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 CQV Engineer Mid-Level 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.

DUTIES AND RESPONSIBILITIES:

• Develop and execute commissioning, qualification, and validation protocols for equipment, facility systems, and utilities, covering Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Conduct risk assessments and impact analyses to ensure the technical accuracy of CQV activities.
• Collaborate with cross-functional teams to coordinate and implement CQV initiatives.
• Prepare and maintain CQV documentation, including plans, test protocols, summary reports, and traceability matrices, ensuring regulatory compliance and accuracy.
• Investigate and resolve deviations encountered during qualification/validation, identifying root causes and implementing corrective actions.
• Provide technical guidance on qualification/validation principles, regulatory requirements, and best practices to internal stakeholders.
• Stay up-to-date with regulatory guidelines, industry trends, and best practices related to validation and quality assurance. Industry Awareness: Stay up-to-date with regulatory guidelines, industry trends, and best practices related to validation and quality assurance.

EDUCATION:

• Bachelor's degree in Engineering, Science, or related field. Advanced degree preferred.

QUALIFICATIONS:

• Minimum of 3 years of experience in CQV within the pharmaceutical, biotechnology, cell therapy or medical device industries. CSV experience is a plus.
• Strong understanding of validation principles and methodologies, including risk-based validation approaches.
• Knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines.
• Experience with Cell Therapy equipment (cell counters, cell processing systems, cell analyzers, bioreactors, etc.) qualification is a plus.

Knowledge, Skills & Abilities:

• Proficient in risk-based validation approaches.
• Strong analytical, problem-solving, and communication skills.
• Ability to work effectively in team settings and collaborate with cross-functional teams.

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.

You can also apply here:

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.

ABOUT US:

SOKOL GxP Services is a rapidly expanding provider of Commissioning, Qualification, and Validation (CQV), Computer System Validation (CSV), and a full suite of GxP services tailored to the pharmaceutical, biotechnology, cell therapy, and medical device industries. Our mission is to help clients achieve regulatory compliance while upholding the highest standards of product quality and safety.

Our customized solutions are designed to guide clients through complex regulatory landscapes, enhancing the efficiency and compliance of their GxP processes. At SOKOL, we’re committed to empowering our clients with the expertise and precision needed to confidently meet and exceed industry standards.

Crafting GxP Excellence!

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.