Equipment Validation Specialist

Ushitecsolutions; Boston (MA); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading biopharmaceutical company in Boston seeks an Equipment Validation Specialist to ensure compliance with regulatory and quality standards in biopharmaceutical manufacturing. The role involves conducting validation activities, supporting audits, and improving validation processes. The ideal candidate holds a Bachelor's degree and has over 4 years of experience in a GMP-regulated environment. Strong knowledge of GMP regulations and validation protocols is essential.

Qualifications

• 4+ years of experience in equipment validation within a biopharmaceutical or GMP-regulated environment.
• Strong understanding of GMP regulations and validation lifecycle processes.
• Knowledge of biopharmaceutical manufacturing equipment, utilities, and controlled environments.

Responsibilities

• Ensure all biopharmaceutical manufacturing equipment meets regulatory and quality standards.
• Perform validation activities including Installation Verification, Steam-In-Place, Autoclaves, and Temperature Mapping.
• Support internal and external audits with accurate validation documentation.

Skills

Equipment validation

GMP regulations

Documentation skills

Collaboration skills

Education

Bachelor’s degree in a scientific, engineering, or technical discipline

Tools

TrackWise

Laboratory Information Management System (LIMS)

Document Management System (DMS)

Job description

As an Equipment Validation Specialist, you will be responsible for ensuring that all biopharmaceutical manufacturing equipment and systems meet regulatory and quality standards.

You will perform and maintain validation activities in compliance with Good Manufacturing Practices (GMP) and company procedures, ensuring equipment remains in a validated state throughout its lifecycle.

Your role will also involve continuous improvement of validation processes and maintaining validated states for all computerized systems.

Equipment Validation and Qualification:

• Perform validation activities including Installation Verification (IV/IQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, and Temperature Mapping of controlled storage rooms and equipment.
• Conduct validation maintenance and requalification to ensure GMP equipment is continuously validated.
• Develop and execute validation protocols based on plans and engineering documentation.
• Organize and maintain validation tools, dataloggers, and probes, ensuring calibration and readiness.
• Provide technical support during review and approval of SOPs, Protocols, Change Controls, Deviations, and CAPA.

Quality Systems and Compliance:

• Ensure validation activities align with GMP and corporate quality standards.
• Perform assigned tasks within systems such as Document Management System (DMS), Laboratory Information Management System (LIMS), and TrackWise Quality System (Change Control, Deviation, CAPA).
• Support internal and external audits with accurate validation documentation.
• Maintain compliance by adhering to all quality and regulatory procedures.

Required Skills:

• Bachelor’s degree in a scientific, engineering, or technical discipline (4-year degree strongly preferred).
• 4+ years of experience in equipment validation within a biopharmaceutical or GMP-regulated environment.
• Strong understanding of GMP regulations and validation lifecycle processes.
• Knowledge of biopharmaceutical manufacturing equipment, utilities, and controlled environments.
• Experience with validation protocols, temperature mapping, and clean utility systems.
• Proficiency with quality systems such as TrackWise, LIMS, and DMS.
• Strong collaboration, documentation, and organizational skills.