CSV/CQV Consultant
Position Summary:
We are looking for a highly motivated, energetic, and detail-oriented CSV/CQV Engineer to join our growing team as a full-time, salaried W-2 employee.
This is an excellent opportunity for an ambitious professional who is excited to build a career in pharmaceutical and biotechnology consulting, learn from experienced industry professionals, and take on increasing responsibility as they grow with our company.
In this role, you will support Commissioning, Qualification, and Computer System Validation (CSV) activities across client projects in regulated pharmaceutical and biotechnology environments. You will have the opportunity to work directly with clients, gain exposure to a variety of systems and technologies, and develop your technical and professional skills in a fast-paced consulting environment.
**Not open to c2c**
Responsibilities
- Support Computer System Validation (CSV) and Commissioning, Qualification, and Validation (CQV) activities for equipment, instruments, and related systems
- Draft, review, and support execution of validation lifecycle documents, including System Impact Assessments, GxP Assessments, System Risk Assessments, User Requirement Specifications, IQ/OQ/PQ protocols, Trace matrices, Summary reports
- Translate system requirements into executable validation protocols and test scripts
- Assist with vendor qualification documentation and ensure required approvals are in place prior to execution
- Track validation deliverables, provide project status updates, and support timeline management
- Work cross-functionally with stakeholders, system owners, vendors, quality, and project teams to drive deliverables to completion
- Support compliance with applicable regulatory and quality requirements, including GMP/GLP and 21 CFR Part 11
- Participate in client meetings and contribute to overall project execution and readiness
Requirements
- Recent graduate with Engineering or Science Major or Minimum 1-2 years of experience in CSV, CQV, equipment qualification, or validation support within the pharmaceutical, biotechnology, or another regulated industry; temperature mapping experience is preferred
- Working knowledge of: GAMP 5, 21 CFR Part 11, Data Integrity, GMP and/or GLP environments
- Strong technical writing and documentation skills
- Working knowledge of GMP regulations and other policies/regulations as applicable.
- Ability to work effectively in a fast-paced environment and communicate professionally with clients, management, and project teams
- Dependable, reliable, professional, and able to work both independently and collaboratively
- Must demonstrate honesty, integrity, and accountability
- Working knowledge of Microsoft Office Applications
- Must have strong understanding of good manufacturing practices and/or good laboratory practices
- Ability to comply with the company code of conduct, policies and regulatory standards
- Must have a strong Technical writing skills
In order to be considered, please answer the following questions listed below:
- How many years of CSV experience do you have?
- How many years of CQV experience do you have?
- How many years of gmp/glp experience do you have?
Resumes will not be considered for those who fail to answer the above questions.
Why Join Us?
If you are someone who is smart, driven, dependable, and eager to learn, this is an opportunity to build a career, not simply fill a position. You will work alongside experienced professionals, gain hands-on exposure to the pharmaceutical and biotechnology industries, and have the opportunity to grow your technical skills and responsibilities within a growing organization. The team is made up of highly technical and highly motivated group of individuals, be part of a winning team.We value character as much as technical ability. If you have the right attitude, strong work ethic, integrity, and desire to learn, we want to hear from you.Full-Time | Salaried W-2 | Career Growth Opportunity
Company
ANSA Compliance is a compliance service, project management, and staffing provider that specializes in serving the pharmaceutical, biotechnology, and medical device industries. With over 20 years of combined experience in the compliance sector, the ANSA team can support clients throughout any stage in the development lifecycle.
ANSA Compliance pledges to create and maintain a workplace where all employees have the chance to participate and contribute to the success of the business. Employees at ANSA Compliance are valued and appreciated for the skills, experience, and unique perspective that they bring.
Job Type: Contract
Pay: $70,000.00 - $100,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Application Question(s):
- To be considered, please answer the following questions:
How many years of CSV experience do you have?
How many years of CQV experience do you have?
How many years of gmp/glp experience do you have?
Resumes will not be considered for those who fail to answer the above questions.
Experience:
- CQV: 2 years (Required)
- Laboratory: 2 years (Required)
- pharmaceutical: 2 years (Required)
- CSV: 3 years (Required)
Work Location: In person
