At Hologic, ensure compliance and quality throughout the manufacturing lifecycle of diagnostic and medical device products
Requirements
- Proficient understanding of validation methods, including process validation, analytical method validation, cleaning validation, and equipment/facility qualification
- Knowledge of risk analysis tools such as PFMEA and process risk assessments
- Working knowledge of regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11
- Familiarity with change control processes and documentation requirements
- Understanding of statistics, Statistical Process Control (SPC), and acceptance sampling plans
- Experience with electronic document management systems
- Proficient in leading cross-functional teams to develop PFMEAs and address process-related non-conformance events
Responsibilities
- lead validation efforts for analytical methods, equipment, processes, and facilities
- drive risk management and supporting regulatory submissions
- contribute to new product introductions
- champion process improvements
- perform validation impact assessments and determine risk-based validation strategies
- author validation protocols, reports, master validation plans, and regulatory submission content
- evaluate specifications and propose improvement projects
Other
- 2–5 years of experience in a diagnostic, medical device, biotech, or pharmaceutical company
- Hands-on experience with validation activities, including analytical method validation, process validation, and equipment/facility qualifications
- Experience with regulatory submissions and understanding of quality systems in regulated industries
- Detail-oriented and organized with a focus on accuracy and compliance
- Committed to training and mentoring new employees to ensure team success
