Computer Software Validation; CSV Consultant Job Quincy area,Massachusetts USA,Software Development

Position: Computer Software Validation (CSV) Consultant

Job Description

Position Overview: We are seeking a highly experienced Computer Software Validation Contractor with 5 years of hands‑on experience in lab and analytical software. The ideal candidate will possess a deep understanding of software validation principles and methodologies, with a specific focus on ensuring compliance within regulated environments.

Key Responsibilities:

Software Validation: Execute validation activities for laboratory and analytical software systems, ensuring compliance with regulatory requirements such as FDA, EU GMP, and other relevant standards.

Documentation: Develop and maintain validation documentation including validation plans, protocols, test scripts, and summary reports in alignment with company SOPs and regulatory guidelines.

Risk Management: Conduct risk assessments to identify and mitigate potential software validation risks, ensuring the integrity of data generated by lab and analytical equipment.

Change Control: Manage change control processes related to software validation activities, ensuring that changes are implemented in a controlled and documented manner.

Cross-functional Collaboration: Collaborate closely with cross-functional teams including Quality Assurance, IT, Engineering, and Operations to ensure alignment of validation activities with overall business objectives.

Controlled Temperature Units: Specifically focus on the validation of software systems associated with controlled temperature units, ensuring accuracy and reliability of temperature monitoring and control.

Qualifications:

Minimum of 5 years of experience in computer software validation within regulated industries, with a focus on lab and analytical equipment and software.
In-depth knowledge of regulatory requirements such as FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
Experience with validation tools and methodologies, including IQ/OQ/PQ, CSV risk assessments, and traceability matrices.
Strong understanding of controlled temperature units and their integration with software systems.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross‑functional teams.

Company Description

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

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Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

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