No C2C or third parties Please (Wont be considerd_
About the Role
We're seeking a part-time CSV Engineer to join our team and support multiple validation projects within our CSA and compliance departments. This is a remote contract position requiring approximately 20 hours per week for three months, with the possibility of transitioning to a full-time onsite role in Verona or Pasadena. In this role, you will author, review, and manage validation documentation for laboratory and manufacturing systems while collaborating with cross-functional teams to ensure compliance.
Key Responsibilities
- Author, review, and manage validation documentation for multiple concurrent CSV and CSA projects.
- Coordinate validation deliverables through approval workflows and oversee document control systems.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and timelines.
- Write and assist in the development of test scripts, providing support to SMEs during testing activities.
- Maintain high-quality documentation in a regulated environment while adapting to shifting priorities.
Qualifications & Skills
- Prior experience as a CSV Engineer with strong understanding of CSV and CSA methodologies in regulated pharmaceutical settings.
- Proficient in creating and managing validation documentation, including plans, specifications, test scripts, and summary reports.
- Capable of handling multiple projects and adjusting to evolving priorities while working collaboratively with cross-functional teams.
- Highly detail-oriented, disciplined, and committed to documentation standards and regulatory compliance.
- Familiarity with laboratory and manufacturing systems such as LIMS, Agilent Open Lab, ChemStation, MassHunter, and temperature monitoring systems is a plus.
- Reliable, communicative, and thrives in dynamic, regulated environments.
Job Type: Contract
Pay: $50.00 per hour
Expected hours: 40 per week
Benefits:
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Experience:
- csv: 5 years (Required)
- SMEs: 5 years (Required)
- Laboratory information management systems: 5 years (Required)
Work Location: Remote
