1 day ago
Base Salary
$68k - $90k/yr
Responsibilities
- Develop software validation strategies for new and revised quality-system and manufacturing software.
- Review and approve validations, test scripts, and reports while providing project guidance and support.
- Support continuous improvement of software validation and controls processes using regulatory and risk-based techniques.
- Support new MES deployments, sustaining activities, and optimization projects as an integrated MES team member.
- Develop MES validation test cases and support Software Verification and Validation activities, including CRS revisions and test-case execution.
- Maintain MES compliance, its validated state, and the integrity of the electronic device history record (eDHR).
Requirements
- Associate’s degree in engineering or a scientific discipline, or an equivalent combination of education and experience.
- At least two years of relevant Computerized System Validation (CSV) experience, or one year of CSV and one year of relevant Process Validation experience, in the medical-device or pharmaceutical industry.
- Experience with 21 CFR Part 11 and GAMP 5 computer-system validation and control requirements.
- Experience with 21 CFR Part 820, ISO 13485, manufacturing principles, and quality-system principles.
- Knowledge of MES, Computer Software Assurance (CSA), ALCOA+, and data-integrity principles.
- Strong written and verbal communication, proofreading, writing, organization, prioritization, attention to detail, and teamwork skills.
- Medical-device industry experience is preferred.
Benefits
- Annual bonus, paid vacation, paid holidays, health, dental, and vision benefits.
- 401(k) with matching contributions, tax-advantaged savings accounts, legal plan, and voluntary life and AD&D insurance.
- Voluntary long-term disability, short-term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.
- Annual salary range of $68,000-$90,000.