Job DescriptionThe 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 escalate 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 escalate issues in a timely manner.
- Contribute to continuous improvement through departmental process improvement goals, improvement projects, and metrics support.
Experience- Requires 1+ 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.
The annualized base salary range for this role is $71,000 - $105,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter NoticeAgencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In 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.
