Computer Software Validation Specialist
2 days ago
We are seeking a highly experienced Computer Software Validation professional to join our team at Beacon Hill Life Sciences - Boston. 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.
- 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.
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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Computer Software Validation Specialist
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Canton, Ohio, United States Beacon Hill Life Sciences - Boston Full timeJob OverviewWe are seeking a highly experienced Computer Software Validation Specialist to join our team at Beacon Hill Life Sciences - Boston. 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 ResponsibilitiesSoftware...
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Software Validation Specialist
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