About the role
Job Description
Hologic is a global leader in women’s health, dedicated to enabling healthier lives everywhere, every day. Through The Science of Sure, we deliver innovative solutions that support healthcare providers in improving access, efficiency and patient outcomes. We are looking for a Quality Engineer III to join our team in San Diego, CA. This role is responsible for planning, executing and documenting validation activities across regulated manufacturing processes. The Quality Engineer II will support validation of analytical methods, cleaning processes, production processes, equipment, facilities, utilities, raw materials, reagents, software and automation systems, and related manufacturing processes.
What To Expect
- Plan, execute and document validation activities from start to finish, including master validation plans, protocols, execution, data review and final reports.
- Develop validation strategies, sampling plans and risk-based approaches for production and process validation.
- Validate analytical methods, cleaning processes, production processes, bulk processes, raw materials, reagents, consumables, equipment, facilities, utilities and software or automation systems.
- Support validation of complex or custom manufacturing equipment, reagent lines, automated systems and software-supported manufacturing processes.
- Generate and maintain process FMEAs for production processes.
- Perform risk assessments for process-related nonconformances, planned deviations, change controls and validation impact assessments.
- Support equipment, facilities, utilities, process and software change controls.
- Provide validation content and technical support for regulatory submissions.
- Support design transfer, production scale-up and cleanroom manufacturing validation as needed.
- Maintain validation documentation and records in accordance with applicable quality system requirements.
- Work cross-functionally with manufacturing, engineering, quality, regulatory and technical teams to support validation deliverables and project timelines.
- Identify validation risks, escalate issues where needed and support continuous improvement of validation practices and quality systems.
What We Expect
- Bachelor’s degree in Science, Chemical Engineering, Biology, Chemistry, Engineering or a related technical discipline.
- Typically 5–8 years of experience in diagnostics, biotechnology or pharmaceuticals.
- Strong validation background, ideally within diagnostics, biotechnology, pharmaceuticals, biologics, vaccines, injectables, consumables or reagents.
- Experience with process validation, analytical method validation, cleaning validation, facility and utility qualification, equipment qualification and software-supported manufacturing processes.
- Ability to own validation work end to end, including strategy, risk assessment, sampling rationale, protocol writing, execution, data review and reporting.
- Experience developing master validation plans, validation protocols, reports, FMEAs, risk assessments and documentation to support regulatory submissions.
- Experience with reagent validation, consumable validation, bulk manufacturing, production line validation or assay-related manufacturing processes.
- Experience with change control processes, documentation requirements, validation impact assessments and electronic document management systems.
- Understanding of statistics, Statistical Process Control and acceptance sampling.
- Working knowledge of applicable FDA and ISO regulations and expectations, including CDRH, CBER, 21 CFR Part 820, 21 CFR Part 11, ISO 13485 and ISO 14971.
- Cleanroom manufacturing experience preferred.
- Design transfer experience beneficial.
- Strong technical writing skills and the ability to produce clear, accurate and inspection-ready validation documentation.
- Strong communication and influencing skills, with the ability to work effectively across functions.
- Ability to mentor others and provide technical guidance within validation and quality activities.
- Detail-oriented, proactive and comfortable managing multiple validation priorities in a regulated environment.
Why Hologic?
- Join a global leader in women’s health and contribute to work that helps improve patient outcomes through innovative healthcare solutions.
- Play a key role in supporting regulated manufacturing processes, helping ensure validation activities are robust, risk-based and aligned with applicable quality and regulatory requirements.
- Be part of a purpose-driven organisation committed to making Hologic the company where top talent comes to grow. We provide comprehensive training when you join, as well as continued development and training throughout your career.