Quality Engineer 3

Hologic is a global leader in womens 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 aQuality Engineer IIIto join our team inSan 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

• Bachelors degree in Science Chemical Engineering Biology Chemistry Engineering or a related technical discipline.
• Typically 58 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 womens 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.

The annualized base salary range for this role isUSD 98500 USD 154000and is bonus eligible. Final compensation packages will depend on factors including relevant experience skillset knowledge geography education business needs and market demand.

#LI-AB1

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.