Computer Systems Validation Lead

Posted 2+ weeks ago

Computer Systems Validation Lead

Job description

32 Stripes is seeking an experienced and highly skilled Computer Systems Validation Lead to join a major life sciences company. In this role, you will be responsible for leading the validation of computerized systems used in the development, manufacturing, and testing of pharmaceutical products. You will ensure that these systems comply with regulatory requirements, industry standards, and company policies.

The Computer Systems Validation Lead will:

Develop and execute computer system validation plans and protocols for new and existing computerized systems
Lead a team of validation professionals and oversee their work
Collaborate with cross-functional teams to ensure that systems are designed, developed, and maintained in compliance with regulations and standards
Perform risk assessments and develop risk mitigation strategies for computerized systems
Ensure that validation documentation is complete, accurate, and maintained in accordance with regulatory requirements
Manage change control for computerized systems and assess the impact of changes on system validation status
Stay current with regulatory requirements and industry standards related to computer system validation

Qualifications

Bachelor’s or advanced degree in computer science, engineering, or related field
At least 5 years of experience in computer system validation, preferably in a regulated industry such as pharmaceuticals, biotechnology, or medical devices
Experience leading a team of validation professionals
Strong knowledge of regulatory requirements and industry standards related to computer system validation, including FDA 21 CFR Part 11 and GAMP 5
Strong analytical and problem-solving skills
Excellent written and verbal communication skills
Ability to work independently and as part of a team
Attention to detail and strong organizational skills

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