Job Information
Sokol Materials & Services CQV Project Manager I in Skillman, New Jersey
CQV Project Manager I
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Job Type
Lead
Workspace
Remote and/or hybrid option
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 a related field is required .
7-10 years of CQV experience within the pharmaceutical, biotechnology, cell therapy, or medical device industries, with 3-5 years in project and people management.
Strong understanding of CQV principles, methodologies, and risk-based validation approaches.
Familiarity with FDA, EMA, and ICH guidelines
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
The CQV Project Manager (PM) will take on a key leadership role, overseeing the scope, schedule, and budget for small to medium-scale CQV projects. This hands-on position involves managing and mentoring a team of 3-5 CQV engineers, engaging in field execution, and actively participating in project activities beyond the desk. We seek a versatile and dynamic PM who can lead with both strategy and technical expertise.
Supervisory Responsibilities: Yes.
DUTIES / RESPONSIBILITIES
__ Knowledge, Skills & Abilities __
Excellent oral and written communication skills in English.
Strong analytical and problem-solving skills.
Proven leadership abilities with the capacity to effectively manage and motivate a team.
Ability to lead cross-functional project teams and manage complex CQV projects.
PMP (Project Management Professional) certification is a plus but not required.
__ Key Responsibilities __
Take responsibility for project scope, schedule, and budget, ensuring alignment with client objectives.
Develop and manage project plans, schedules, and budgets for CQV activities.
Coordinate and lead project meetings, providing updates and reports to stakeholders.
Ensure project milestones and deliverables are achieved on time and within budget.
Oversee the commissioning, qualification, and validation (CQV) of equipment, systems, and processes.
Develop and review CQV documentation, including protocols, reports, and SOPs.
Ensure compliance with regulatory requirements and industry standards.
Lead and mentor a team of CQV engineers, providing guidance and technical support.
Collaborate with cross-functional teams, including engineering, quality, and operations.
Facilitate training and development for team members on CQV processes and industry standards.
Ensure all CQV activities adhere to regulatory requirements (e.g., FDA, EMA).
Maintain up-to-date knowledge of industry trends and regulatory changes.
Conduct audits and inspections to verify compliance and preparedness for regulatory reviews.
Identify potential project risks and develop effective mitigation strategies.
Conduct risk assessments and implement corrective actions as needed.
Monitor and report on the status of risk management activities.
Promote continuous improvement within CQV processes and practices.
Implement best practices and innovative solutions to enhance efficiency and quality.
Evaluate project outcomes and apply lessons learned to future projects.
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.