Target Hiring Date
January 2025
Salary
$40-50 Per Hour
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 preferable. Advanced degree preferred.
Minimum of 3 years of experience in CQV and/or CSV within the pharmaceutical, biotechnology, cell therapy or medical device industries.
Experience with Cell Therapy equipment (cell counters, cell processing systems, cell analyzers, bioreactors, etc.) qualification 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.
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
DUTIES / 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.
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.