Job Information
RCM Technologies Senior Computer Systems Validation Consultant in United States
Contract role, 40 hrs / week Title or Role: Computer System Validation Compensation: up to $45/hour - commensurate with experience Location: 100 % Remote Length of Contract: 9 months+ Primary Responsibilities
Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems.
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.
Understands how aspects of data integrity, security, access, and safety are addressed through the various protocols.
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.
Validates software for Laboratory and Manufacturing instruments.
Available to attend meetings as necessary
Periodic Review activities
Ability to manage three to four active projects
Applications to support
Waters/Empower
Various Laboratory Instrument Software
Various Manufacturing Instruments Software
Other Enterprise Applications as Required
Qualifications
Minimum of +7 years in the FDA regulated industry.
5+ years Document Authoring experience, SOP revisioning experience and re-executing protocols
Working knowledge of GMP, 21 CFR Part 11 and Annex 11.
Ability to work on multiple concurrent project initiatives.
Experience with Laboratory and Manufacturing Instrument Software Validation.
Experience in validating Enterprise systems (both on premise and cloud). Examples are SAP, Empower, Labware, Veeva.
Worked with different validation models from V-Model to CSA.
Ability to apply Agile and Waterfall methodology.
Excellent written and verbal communication skills.
Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
Strong collaboration with colleagues at all levels.
Strong customer service and teamwork oriented.
Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
Highly flexible, adapting to changes in priorities, requirements and processes is required.
Education
BS/BA required in a related field.
5+ years minimum required relevant experience.
Equal Opportunity Statement: 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.