CQV Engineer Senior Level

CQV Engineer Senior Level

Job Location

Skillman, NJ

Workspace

On-site position (no remote or hybrid options)

Target Hiring Date

TBD

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.

Requirements

Education and Experience :

Bachelor’s degree in Engineering, Science, or a related field is required; an advanced degree is preferred.

Minimum of 7 years of CQV experience in pharmaceutical, biotechnology, cell therapy, or medical device industries, with at least 5 years focused on utilities and facility qualification.

Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA, EMA, and ICH guidelines.

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.

Physical Requirements :

Prolonged periods of sitting and computer use.

Must be able to lift up to 15 pounds occasionally.

About the Role

• As a Senior-Level Validation Engineer at Sokol GxP Services, you will be instrumental in commissioning, qualifying, and validating laboratory equipment, facility systems, and utilities at multi-use sites. Collaborating with internal teams and external service providers, you will ensure that critical CQV activities align with regulatory standards and best practices. This role requires a professional with analytical acumen, problem-solving expertise, and the ability to work seamlessly with cross-functional teams.
• Supervisory Responsibilities : None.

DUTIES AND RESPONSIBILITIES

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About the Company

Join Sokol GxP Services – Where Innovation Meets Integrity!

Join Sokol GxP Services, where we partner with leading pharmaceutical and biotech companies to provide exceptional Commissioning, Qualification, and Validation (CQV) services. We are committed to fostering diversity, empowering local talent, and building strong community connections to bring the best-qualified candidates to our clients in the Summit, NJ area. Our inclusive and collaborative culture promotes growth and innovation, offering competitive health benefits, PTO, holiday pay, volunteer hours, a relocation budget

Let’s shape the future of life sciences together!

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

Equal Opportunity Employer Statement :

Sokol GxP Services is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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.

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