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CSV Specialist (Lab systems)
RCM Technologies, Inc. | Life Sciences / Data & Solutions
- 🇵🇷 Puerto Rico
- Remote
- 1 day ago
- GxP
- GMP
- SAP
- Veeva
- Agile
- Waterfall
1 day ago
Job Title: Senior Computer System Validation (CSV) Specialist
Pay Rate:Up to $50/hr., commensurates with expereince
Location: Remote
Primary Responsibilities
- Lead and manage computer system validation (CSV) projects, including authoring and executing specifications and validation documentation for enterprise systems.
- Develop and author validation protocols ensuring compliance with 21 CFR Part 11, Annex 11, GxP, and internal corporate policies.
- Perform reviews and remote execution of validation protocols in accordance with cGMP, ISPE GAMP 5, and corporate standards.
- Ensure data integrity, system security, access control, and user safety are adequately addressed within validation documentation.
- Conduct risk assessments and prepare validation summary reports aligned with GMP and regulatory requirements.
- Investigate and support resolution of Deviations, CAPAs, and other quality system activities, including Periodic Reviews.
- Create comprehensive validation deliverables, including plans, specifications, protocols, traceability matrices, and change controls.
- Validate software for manufacturing instruments while managing up to four concurrent validation projects.
Applications to support
- Waters/Empower/OSI PI/MODA/Unicorn/Process Pad or products serving the same function
- Various Manufacturing Instruments Software
- Other Enterprise Applications as Required
- 7+ years of experience in FDA-regulated industries with strong knowledge of GMP, 21 CFR Part 11, and Annex 11.
- 5+ years of experience in document authoring, SOP revisions, and protocol re-execution.
- Demonstrated ability to manage multiple concurrent validation or system implementation projects.
- Experience validating software for manufacturing instruments, as well as enterprise systems such as SAP, Empower, and Veeva or similar.
- Proficient in both traditional (V-Model) and modern (CSA) validation approaches.
- Familiarity with Agile and Waterfall methodologies in system and software development environments.
- Excellent written and verbal communication skills; strong collaborator with cross-functional teams.
- Self-motivated, adaptable, and customer-focused, with a proactive approach to leadership and problem-solving.
Education
- BS/BA required in a related field.
- 5+ years minimum required relevant experience.
About RCM:
RCM Life Sciences / Data Solutions is a leading provider of Engineering and IT Business Solutions Services to over 1,000 clients in the commercial and government sectors. 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 & PR.
Equal Opportunity Statement
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. 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.
Equal Opportunity Employer:
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.
About RCM:
RCM is publicly traded on Nasdaq under the symbol RCMT. RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial.
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.
CSV Specialist (Lab systems) · RCM Technologies, Inc. | Life Sciences / Data & Solutions