Senior CSV Specialist

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 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.
• 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.

Qualifications

• Minimum of 5+ years in the Life Sciences industry.
• Working knowledge of 21 CFR Part 11 and Annex 11.
• Ability to work on multiple concurrent project initiatives.
• 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.
• 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

Job Type: Contract

Pay: $45.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance

Experience level:

• 7 years

Schedule:

• 8 hour shift
• Day shift

People with a criminal record are encouraged to apply

Work Location: Remote