Target Hiring Date
January 2025
Salary
$45 - 55 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 a related field is required; an advanced degree is preferred.
Minimum of 5 years in CQV within the pharmaceutical, biotechnology, cell therapy, or medical device industries.
Experience with CTU and autoclave qualification/validation is a plus.
Strong understanding of validation principles, methodologies, and risk-based approaches, including familiarity with FDA, EMA, and ICH guidelines.
Proven leadership abilities with the capacity to manage, motivate, and inspire a team effectively.
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.
About the Role
As the Lead Validation Specialist, you will lead the development and execution of CQV protocols, provide technical expertise, and manage a team to ensure high-quality validation outcomes. This role is ideal for an experienced professional with strong leadership capabilities, regulatory knowledge, and technical CQV expertise.
Supervisory Responsibilities: Yes.
DUTIES / RESPONSIBILITIES
________ Knowledge, Skills & Abilities ________
- Excellent analytical, problem-solving, and communication skills.
- Demonstrated ability to lead complex CQV projects with cross-functional teams.
- Strong organizational and time-management skills to handle multiple priorities.
________ Key Responsibilities ________
- Supervise the development and execution of commissioning, qualification, and validation protocols for equipment, facility systems, utilities, and processes, including Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Conduct risk assessments and impact analyses to identify critical validation requirements and mitigate compliance risks.
- Coordinate with cross-functional teams to plan and implement CQV activities effectively.
- Oversee the preparation of CQV deliverables, including plans, summary reports, and traceability matrices, ensuring technical accuracy and regulatory compliance.
- Investigate and resolve deviations during validation activities, working with stakeholders to determine root causes and implement corrective actions.
- Provide leadership and technical guidance on CQV principles, requirements, and best practices to team members, fostering a culture of continuous improvement and learning.
- Stay informed on regulatory guidelines, industry trends, and best practices in 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!
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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.