CSV, Validation Engineer, Mid-Level

Job Title: CSV, Mid-Level Validation EngineerDepartment: Human ResourcesLocation: Skillman, New JerseyJob Type: On-site position (no remote or hybrid options).Reports to: TBDEffective Date: ASAP (within 2 weeks)Pay range: $40 - $50 per hourFLSA Classification: Full-Time | Non-ExemptWork authorization: Applicants must have the legal right to work in the United States without requiring sponsorship. Corp-to-Corp (C2C) arrangements are not accepted.About 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, a 401K * program, and professional development opportunities. Plus, take advantage of our Employee Referral program! Be part of a dynamic team with fantastic opportunities for growth and professional development!Let’s shape the future of life sciences together!Job Summary: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.Supervisory Responsibilities: (None)Duties/Responsibilities:Knowledge, Skills & Abilities:•Proficient in MS Windows, networking basics, and Microsoft Office Suite.•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.Key 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 and Experience:•Bachelor’s degree in engineering, computer science, or a related field (required).•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.Physical Requirements: •Prolonged periods of sitting at a desk and working on a computer.•Must be able to lift up to 15 pounds at times. How to apply: https://www.sokolservices.com/open-positionsAll 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. Relocation support will be determined on a case-by-case basis. * Our 401K program is set to launch in the 2025 fiscal year.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.