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Computer System Validation Specialist
1 week ago
Title or Role: CSV Specialist
Compensation: $50/hr
Location: Remote - Puerto Rico based
Length of Contract: 4 months with strong likelihood to extend 12 additional months
Description:
- Validates software for Laboratory and Manufacturing software and instruments.
- Understands how aspects of data integrity, security, access, and safety are addressed through the various protocols.
- Available to attend online meetings as necessary
- Ability to manage three to four active projects
- Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems as directed by division manager.
- Author validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e., 21 CFR Part 11, Annex 11, GxP, local and corporate policies).
- Review and (remote) execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP 5 guidelines and regulations.
- Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols.
- Assist, investigate and resolve Deviations, CAPA investigations and other potential issues.
- Develops validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
- Minimum of +7 years in the FDA regulated industry, with 5+ years of document authoring experience, SOP revisioning experience, experience re-executing protocols, and with different validation models from V-Model to CSA.
- Working knowledge of GMP, 21 CFR Part 11 and Annex 11.
- Experience with Laboratory and Manufacturing Instrument Software Validation.
- Experience in validating Enterprise systems (both on premise and cloud). Examples are SAP, Empower, MODA, Labware, Veeva, Cohesity, and familiarity with a several of the following: Blue Mountain, ComplianceWire, Labvantage, Sciex, Softmax Pro, Nugenesis.
- Excellent written and verbal communication skills.
- Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
- Strong collaboration and customer service style..
- Highly flexible, easily adapting to change, and ability to take initiative/lead by example.
- Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Information Technology) preferred.
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Pay Transparency:
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.
Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
About RCM:
RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.
