embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. The Site Validation Engineer is responsible for execution and implementation of validation initiatives in support of product design activities and maintenance of the site validation process. Additional responsibilities include cross functional support for the Quality Engineering and Quality Systems group as well as active participation in preparation and conduction of FDA, ISO, or other 3rd party audits. This position is also responsible for validation and GMP/Compliance Training within the plant in conjunction with the Quality Systems and Quality Engineering Leaders. This position is responsible to build sound technical and organizational competence within area of responsibility. Ensure the systems comply with applicable government regulations and standards. Comply with all embecta quality policies, procedures, and practices through consistent application of sound quality engineering/assurance principles. Essential functions include but are not limited to:
- Support the plant on assigned new and existing product initiatives with technical expertise and determine associated resource needs to accomplish project goals.
- Develop and maintain the Validation Master Plan and validation tracking schedule.
- Provide visibility related to all validation activities through tracking and reporting plant metrics.
- Support and influence change management within the plant: liaison between the core team, program managers, and Global quality.
- Conduct training relevant to validation process and procedures.
- Approve protocols and reports for all validation and change control activities to ensure compliance to established procedures.
- Participate in Global validation team meetings as required.
- Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.
- Provide leadership and function as a respondent during FDA, ISO, Corporate or other 3rd party audits.
- Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles.
- Build interactive working and strategic relationships between company Holdrege manufacturing, business and corporate quality management and other staff.
- Perform other duties as assigned by the Team Leader and required to support the needs of the business.
Basic Requirements: - B.S. degree
- 3+ Years of Quality experience including Validation and Quality Engineering responsibilities.
- Statistical and problem-solving skills
- Strong understanding of failure analysis
- Experience with Statistical software
Preferred Requirements: - Demonstrate success with statistical and problem-solving methodologies.
- Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation process on medical devices.
- Strong understanding of failure analysis, test methods and engineering tolerances.
- Strong verbal, written and interpersonal skills.
- Proficient with Minitab or other statistical software, MS Word, Excel, and MS project.
- Six Sigma Certification
- ASQ CQE
- Working knowledge of 21CFR820, ISO 13485.
- Project management experience
embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.