Validation Specialist

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

Job summary

A leading company in pharmaceutical manufacturing is seeking an Equipment Validation Specialist for a 12-month contract in Portsmouth, NH. This role focuses on ensuring compliance and maintaining validation of critical equipment and systems. Ideal candidates will possess strong expertise in GMP regulations and biopharmaceutical processes.

Qualifications

• Mid-Senior level position requiring a strong understanding of equipment validation processes.
• Experience in biopharmaceutical manufacturing or similar fields is desirable.
• Knowledge of related regulatory guidelines and quality assurance practices.

Responsibilities

• Ensure all GMP equipment is validated and maintained according to regulations.
• Program and organize validation equipment and supplies.
• Develop protocols from plans and engineering specifications.

Skills

GMP Compliance

Equipment Validation

Technical Support

Job description

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Base pay range

$75.00/hr - $80.00/hr

Direct message the job poster from Aequor

Job Title: Equipment Validation Specialist

Location: Portsmouth, NH

Duration: 12 Months

Job Description:

• Equipment Validation Specialist exists to ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines.
• The role provide Operations, Quality Assurance and regulatory bodies with scientifically sound, documented evidence that systems and processes will perform as required so they can be assured of a quality, compliant manufacturing environment.
• Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated state.
• Program, organize, and maintain Validation equipment and supplies including dataloggers and probes.
• Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment.
• Develop validation protocols from plans and engineering documents.
• Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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