Job description

Job Description:Title: CSV EngineerLocation: Raritan NJ – (Onsite )Type: Contract (12+ months)Openings: 1

• Minimum 4 years in CSV, having exposure in Medical Device/Med Tech sector, Pharma.

• Clear understanding of principle, procedures and governance of validation activities and IT controls

• Working Knowledge of regulations: 21 CFR Part 11 / 210/ 211 and Annex 11

• Understanding of quality risk-management concepts (ICH Q9)

• Experience in systems validation and quality frameworks

• Perform quality review of relevant validation documentation pre and post execution for accuracy, completeness and ensures compliance with regulatory and client requirements.

• Experience in executing change control and document management

• Strong Knowledge of GAMP5 and Quality Systems

• Experience on decommission, Archiving and Data Integrity (ALOCA+)

• Experience in supporting Data Migrations from validation perspective

• Ability to communicate and work independently with Technical teams

• Adept with Agile and Waterfall methodology based software development and has prior experience in computer system validation using agile methodology

• Prior experience in using of tools like ALM, Document Management system (EDMS), ServiceNow and JIRA

Job Type: Contract

Pay: $60.00 - $65.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Raritan, NJ: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

www.colinoncars.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.colinoncars.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, www.colinoncars.com is the ideal place to find your next job.