Job Information
Sokol Materials & Services CQV Validation Engineer Mid-Level Facilities and Utilities in Skillman, New Jersey
CQV Validation Engineer Mid-Level Facilities and Utilities
Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1)
Job Type
Validation Engineer
Workspace
On-site position (no remote or hybrid options)
Target Hiring Date
January 2025
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 related field. Advanced degree preferred.
Minimum of 3 years of experience in CQV within the pharmaceutical, biotechnology, cell therapy or medical device industries.
Experience with Facilities and Utilities commissioning and qualification.
Must be able read and interpret engineering drawings, P&IDs, wiring diagrams, and other technical documentation.
Strong understanding of validation principles and methodologies, including risk-based validation approaches.
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.
Physical Requirements:
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.
About the Role
As a CQV Engineer Mid at SOKOL GxP Services, you will be instrumental in supporting the commissioning, qualification, and validation services of equipment and utility systems at client sites. Working closely with internal teams and external service providers, you will contribute to key project milestones for facility, utility, and equipment qualification. Under general supervision, you will independently perform routine tasks, leveraging your analytical skills to address common challenges effectively. This role is ideal for a proactive professional eager to learn, collaborate, and build strong relationships across the organization.
DUTIES AND RESPONSIBILITIES:
Create and execute commissioning, qualification, validation protocols for equipment, facility systems, and utilities. These protocols include Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Perform commissioning, qualification activities for facility and utility systems, including HVAC, cleanrooms, water purification systems, steam systems, compressed gases, and other critical utilities.
Conduct field inspections including piping and equipment walk downs, operational startup and troubleshooting.
Conduct risk assessments and impact analyses.
Work with cross-functional teams to coordinate and carry out CQV activities.
Develop CQV documentation, including plans, test protocols, summary reports, and traceability matrices, ensuring technical accuracy and compliance with regulatory requirements.
Investigate and address deviations encountered during qualification/validation activities, working closely with relevant stakeholders to identify root causes and implement corrective actions.
Provide technical guidance and expertise on qualification/validation principles, requirements, and best practices to internal stakeholders.
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, 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!
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.
*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.