Target Hiring Date
January 2025
Salary
No Degree Range: $30-35 Per Hour. Degree Range: $30-40 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 preferable.
Prior internship or coursework in CQV or Quality Assurance (QA) is a plus but not required.
Knowledge, Skills & Abilities:
Strong interest in pursuing a career in CQV within the pharmaceutical, biotechnology, or medical device industries.
Excellent organizational skills and attention to detail.
Ability to analyze data and communicate findings effectively.
Effective team collaboration skills and a willingness to learn and adapt.
Physical Requirements:
Prolonged periods of sitting and computer use.
Must be able to lift up to 15 pounds occasionally.
About the Role
As an Entry-Level Validation Engineer at Sokol GxP Services, you will be instrumental in commissioning, qualifying, and validating laboratory equipment, facility systems, and utilities at multi-use sites. Collaborating with internal teams and external service providers, you will ensure that critical CQV activities align with regulatory standards and best practices. This role requires a professional with analytical acumen, problem-solving expertise, and the ability to work seamlessly with cross-functional teams.
DUTIES / RESPONSIBILITIES
- Assist in developing and executing CQV protocols, including Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, systems, and processes.
- Support risk assessments and impact analyses to identify essential validation requirements and potential compliance risks.
- Work with cross-functional teams, including Quality Assurance (QA), Quality Control (QC), Manufacturing, and Engineering, to coordinate and execute CQV activities.
- Review validation documentation under the guidance of senior team members, ensuring compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) and regulatory standards.
- Gain knowledge of validation principles, requirements, and best practices through on-the-job training and mentorship.
- Engage in internal training programs and workshops to advance skills in validation and quality assurance.
- Stay updated on regulatory guidelines, industry trends, and best practices in validation.
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.