Carrier Computer Systems Validation Lead - Beverly, Massachusetts
CAM60: Sensitech, Inc 800 Cummings Center, Beverly, MA, 01915 USA
Carrier is the leading global provider of healthy, safe and sustainable building and cold chain solutions with a world-class, diverse workforce. We make modern life possible by delivering safer, smarter and more sustainable services that make a difference to people and our planet while revolutionizing industry trends.
About this role
As a Computer Systems Validation Lead, you will lead and manage the Validation Program for Sensitech systems and products. The Validation Lead will work with the Sales, Product, Engineering, and Professional Services teams in the requirements development and execution of validation projects to maintain regulatory compliance, meet industry best practices, and align with business expectations.
Key Responsibilities:
- Define and maintain a global Computer System Validation (CSV) methodology and policies/procedures in accordance with current regulatory guidelines.
- Participate in sales and program design phase to identify customer validation requirements.
- Lead and manage all validation projects and activities for the development and release of products, in accordance with CSV and regulatory requirements.
- Oversee the execution of validation activities, including installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and user acceptance testing (UAT).
- Maintain and update validation documentation, ensuring its accuracy and completeness.
- Evaluate proposed changes to validated systems and recommend level of validation support required.
- Lead internal audits of CSV activities, protocols, and procedures.
- Identify, document, and track non-conformances and corrective/preventative actions related to validation activities.
- Pursue continuous improvement opportunities to ensure effectiveness of the validation program.
- Stay current on the latest GxP regulations and industry best practices for Computer System Validation.
- Conduct risk assessments to identify potential validation gaps and propose mitigation strategies.
- Provide appropriate training and guidance to employees and partners on CSV procedures and policies.
- Identify, track, and provide response plans for key performance indicators.
Basic Qualifications:
- HS Diploma with 5 years of Computer System Validation experience
- 5+ years of experience managing cross-functional projects
- Up to 5% travel required
Preferred Qualifications:
- Bachelor’s Degree in Quality or Engineering
- Experience with Medical Device Product Validation a Plus
- Experience and knowledge of ISO 9001 and ISO 17025 requirements
- Knowledge in the application of 21 CFR Part 11 and Annex 11
- Knowledge of GxP regulations and their application to CSV
- Exceptionally strong written and verbal communication skills
- Ability to manage and prioritize multiple projects
- Experience with validation methodologies and tools
- Results driven with a strong customer and quality focus
- Ability to provide guidance and execute in the development of validation documents and protocols
- Demonstrated ability to develop strong relationships and work with staff, colleagues, cross-functional teams, and third parties
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Carrier is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other federally protected class.
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