Quality Engineer 2

Hologic, Inc.; San Diego (CA); On-site; USD 80,000 - 125,000; Full time

Job summary

Hologic, Inc. is seeking a Validation Engineer to lead validation activities across analytical methods, cleaning, production processes, equipment and facilities qualification.

You will develop and maintain master validation plans, write validation protocols and reports, perform risk assessments, and support regulatory submissions and change controls while guiding PFMEA processes.

Qualifications

• Must have BS in Science or Engineering and knowledge of FDA/ISO regulations (21 CFR Part 820, ISO 13485).
• Experience with PFMEA and risk-based validation.
• Proficiency with validation documentation and electronic records systems.
• Familiarity with change control processes and regulatory submissions.

Responsibilities

• Provide Quality leadership to validation efforts across methods, cleaning, processes, and equipment.
• Author and review master validation plans and validation protocols and reports.
• Lead PFMEAs and risk assessments for process changes and non-conformances.
• Support regulatory submissions and change controls; maintain validated state and lifecycle records.
• Train staff and collaborate with cross-functional teams on NPI and sustaining projects.

Skills

Validation methods

Process validation

Analytical method validation

Cleaning validation

Facility qualification

Equipment qualification

Change control

Electronic document management

PFMEA

Education

Bachelor's degree in Science or Engineering

Job description

The position is responsible for validation activities covering analytical methods, cleaning, production processes, equipment qualification, facilities/utilities qualification, and raw materials qualification.

The role also includes generating and maintaining process FMEA, performing risk assessments for process-related non-conformances and planned deviations, supporting regulatory submissions, writing master validation plans, protocols, and reports, supporting equipment and facilities change controls, and performing validation impact assessments for change orders

Responsibilities

• Provide Quality leadership to new product development teams in validation, design transfer, risk management, and specification development.
• Author master validation plans and reports.
• Author and execute validation protocols and reports for analytical methods, equipment, facilities/utilities, raw materials, process, and cleaning.
• Review the quality, validation impact, and completeness of document change order requests and equipment or facilities change controls.
• Determine validation strategy using an acceptable risk-based approach.
• Lead cross-functional teams to write PFMEAs under limited supervision.
• Perform process risk assessments for Non-Conformance Events and planned deviations.
• Maintain validation records and support cross-functional teams during New Product Introduction and Sustaining projects.
• Review regulatory submissions and notifications under limited supervision.
• Propose improvement projects using supporting data and flowcharts.
• Assist in updating departmental procedures and controlled documents.
• Evaluate specifications for new or modified process designs under limited supervision.
• Lead department and cross-department projects, determine QE deliverables, and help create project timelines.
• Participate in process design reviews, department process improvements, and department metrics reporting.
• Assist Quality Engineering management in Material Review Board and Production Response Team meetings.
• Provide management with status updates and elevate issues in a timely manner.
• Train new employees.

Knowledge

• Bachelor’s degree in Science or Engineering is required.
• Working knowledge of CDRH, CBER, and ISO regulations, including 21 CFR Part 820, ISO 13485, and ISO 14971, is required.
• Working knowledge of 21 CFR Part 11 is required.
• Must follow all applicable FDA regulations and ISO requirements.
• Understanding of statistics, SPC, and acceptance sampling is required.

Skills

• Proficient in validation methods and evaluation criteria.
• Experience with process validation, analytical method validation, cleaning validation, facility/utility qualification, and equipment qualification.
• Experience with change control processes and documentation requirements.
• Experience with electronic document management systems.
• Experience with risk analysis and PFMEA.

Behavior

• Demonstrate Quality leadership in cross-functional and new product development settings.
• Work under limited supervision when leading PFMEAs, reviewing regulatory submissions, evaluating specifications, and leading department or cross-department projects.
• Support collaboration across teams during NPI and Sustaining projects.
• Communicate progress to management and elevate issues in a timely manner.
• Contribute to continuous improvement through departmental process improvement goals, improvement projects, and metrics support.

Experience

• Requires 2+ years of experience in a diagnostic, medical device, biotech, or pharmaceutical company.
• Experience should include validation activities, change control, electronic document management systems, risk analysis, and PFMEA.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so 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 is $79,700 - $124,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

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