Validation Specialist

Tailored Management; Portsmouth (NH); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in the pharmaceutical manufacturing sector seeks a CSV Analytical and Enterprise Validation Specialist to lead critical validation activities and ensure compliance. You will support various departments in achieving quality control, operational success, and effective troubleshooting while managing significant documentation requirements. This role is part of an extended contract and offers competitive hourly pay along with health benefits.

Benefits

Medical insurance

Vision insurance

Dental benefits

Qualifications

• 5-10 years of relevant experience.
• Experience in CSV and analytical systems.
• Ability to create and revise SOPs.

Responsibilities

• Lead validation activities including software updates and system introduction.
• Support updates for operational compliance.
• Review and approve Installation Qualifications and Operational Qualifications.

Skills

Validation Activities

Troubleshooting

Compliance

Risk Assessment

Data Integrity

Education

Bachelor of Science in Science related discipline

Job description

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Base pay range

$40.00/hr - $59.00/hr

Direct message the job poster from Tailored Management

Operations - Recruiting Manager @ Tailored Management | MBA | Full-Life Cycle Recruiting | Contingent workforce | MSP-VMS

Job Title: CSV Analytical and Enterprise Validation Specialist

Location: 101 International Drive, Portsmouth, NH – 03801

Contract: 12+ months duration (Extended or Conversion to FTE)

Payrate: $39.90 - $59.49 per Hr on W2 along with Vision, Dental and Medical Benefits.

Job Description:

• CSV, Analytical and Enterprise Validation specialist IV will lead validation activities including, but not limited to, software updates, new system introduction, Administration of systems and applications, and decommissioning activities as appropriate.
• This person will work closely with other functional groups like Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to support updates to help the site remain in compliance and contribute to quality, on-time delivery and right first-time performance.
• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of CSV, analytical and enterprise systems/applications.
• Review and Approval of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
• Assist in generating User Requirements Specification Documentation, Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
• Prepare Administration and Configuration specification document with support from vendor user manual.
• Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.
• Performs user and application software administration on Enterprise systems. Works on troubleshooting assignments that are complex in nature where considerable judgment and initiative are required in making creative and effective recommendations to solve problems.
• Create and or Revise SOPs for CSV, Analytical and enterprise systems and applications.
• Participate on Risk Assessments
• Perform other duties as assigned.

Education & Experience:

• Bachelor of Science: Science related discipline or relevant experience in the field.
• Experience: 5 - 10 Years

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Manufacturing, Science, and Engineering

• Industries

  Manufacturing, Pharmaceutical Manufacturing, and Retail Building Materials and Garden Equipment

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Inferred from the description for this job

Medical insurance

Vision insurance

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