Sokol Materials & Services
Lead Validation Specialist
Sokol Materials & Services, Skillman, New Jersey, us, 08558
Lead Validation Specialist
Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1)
Job Type
Validation Engineer
Workspace
On-Site
About the Role
• Supervise the development and execution of commissioning, qualification, validation protocols for equipment, facility systems, utilities, and processes encompassing Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Conduct risk assessments and impact analyses to determine critical validation requirements and potential compliance risks.
• Coordinate with cross-functional teams to plan and conduct CQV activities.
• Prepare CQV deliverables, including plans, summary reports, and traceability matrices, ensuring technical accuracy and regulatory compliance.
• Investigate and resolve deviations encountered during validation activities, collaborating closely with stakeholders to identify root causes and implement corrective actions.
• Provide leadership, technical guidance, and expertise on CQV principles, requirements, and best practices to team members.
• Stay updated on regulatory guidelines, industry trends, and best practices related to validation and quality assurance.
Salary Range per Hour:
$45 - 55
Benefits:
PTO
Health Insurance
Paid Holidays
Relocation Bonus
Company Laptop
Work Authorization:
Please note that unfortunately at this time SOKOL GxP Services does not provide H1B visa sponsorship or hire candidates requiring visa sponsorship. Applicants must have the legal right to work in the United States without needing sponsorship.
Requirements
Bachelor's degree in Engineering, Science, or related field is
preferable. A dvanced degree preferred.
Minimum of 5 years of CQV experience in the pharmaceutical, biotechnology, cell therapy or medical device industries.
Experience with CTU and autoclaves qualification/validation is a plus.
Strong grasp of CQV 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.
Proven leadership abilities with the capacity to effectively manage and motivate a team.
About the Company
SOKOL GxP Services is a growing Commissioning Qualification Validation (CQV) service provider that specializes in assisting pharmaceutical, biotechnology, cell therapy and medical device companies. Our primary goal is to help our clients achieve regulatory compliance and ensure the quality and safety of their products. We have a team of experienced professionals that offers comprehensive CQV services, including equipment, utilities, and facility commissioning, qualification and validation. Our tailored solutions are designed to help our clients navigate complex regulatory requirements and optimize their CQV processes to meet industry standards efficiently and effectively.
Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1)
Job Type
Validation Engineer
Workspace
On-Site
About the Role
• Supervise the development and execution of commissioning, qualification, validation protocols for equipment, facility systems, utilities, and processes encompassing Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Conduct risk assessments and impact analyses to determine critical validation requirements and potential compliance risks.
• Coordinate with cross-functional teams to plan and conduct CQV activities.
• Prepare CQV deliverables, including plans, summary reports, and traceability matrices, ensuring technical accuracy and regulatory compliance.
• Investigate and resolve deviations encountered during validation activities, collaborating closely with stakeholders to identify root causes and implement corrective actions.
• Provide leadership, technical guidance, and expertise on CQV principles, requirements, and best practices to team members.
• Stay updated on regulatory guidelines, industry trends, and best practices related to validation and quality assurance.
Salary Range per Hour:
$45 - 55
Benefits:
PTO
Health Insurance
Paid Holidays
Relocation Bonus
Company Laptop
Work Authorization:
Please note that unfortunately at this time SOKOL GxP Services does not provide H1B visa sponsorship or hire candidates requiring visa sponsorship. Applicants must have the legal right to work in the United States without needing sponsorship.
Requirements
Bachelor's degree in Engineering, Science, or related field is
preferable. A dvanced degree preferred.
Minimum of 5 years of CQV experience in the pharmaceutical, biotechnology, cell therapy or medical device industries.
Experience with CTU and autoclaves qualification/validation is a plus.
Strong grasp of CQV 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.
Proven leadership abilities with the capacity to effectively manage and motivate a team.
About the Company
SOKOL GxP Services is a growing Commissioning Qualification Validation (CQV) service provider that specializes in assisting pharmaceutical, biotechnology, cell therapy and medical device companies. Our primary goal is to help our clients achieve regulatory compliance and ensure the quality and safety of their products. We have a team of experienced professionals that offers comprehensive CQV services, including equipment, utilities, and facility commissioning, qualification and validation. Our tailored solutions are designed to help our clients navigate complex regulatory requirements and optimize their CQV processes to meet industry standards efficiently and effectively.