Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.
Job Description Summary
The Principal Quality Engineer independently supports the most complex projects, collaborating with other quality, engineering, and manufacturing operations functions to ensure the quality aspects of validation and qualification activities, performing various types of analysis and generating and reviewing internal investigations, CAPAs, and change controls. Leads multi-functional teams in special, highly sensitive, and/or cross-site projects. Leads investigations, corrective actions, continuous improvement projects, and process capability improvements. Coaches personnel across departments in quality processes and mentors more junior Quality Engineers in the use of decision-making tools.
Job Description
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Validation & Qualification
Independently supporting the most complex projects, collaborates with other quality, engineering, and manufacturing operations functions ensure all quality aspects of validation and qualification activities at the site including process validation, packaging validation, computer validation (URS), IQ, OQ and PQ.
Provides subject matter expertise to support other departments (e.g. change controls, SOPs, CAPAs, investigation etc.) to ensure compliance with cGMPs.
Leads investigations, corrective actions, continuous improvement projects, and process capability improvements (FMEA, root cause analysis, process mapping, Six Sigma, SPC, DOE, etc.).
Travel to CMO sites
5% of Time
Minimal acceptable level of education, work experience and certificationsrequired for the job
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Expert knowledge of statistics, failure modes and effects analysis, root cause analysis, process mapping, statistical process control, design of experiments, and other related engineering tools.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writingetc.
Adaptability - Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Commitment to Diversity, Equity, and Inclusion:
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.