Validation Engineer

Regulatory Toolkit; Holdrege (NE); On-site; USD 75,000 - 110,000; Full time

Job summary

embecta, a global medical device company, is seeking a Site Validation Engineer in Nebraska to execute validation initiatives supporting product design and maintain the validation program. You will collaborate with Quality Systems and Quality Engineering to uphold rigorous standards and drive improvements.

The role requires a BS in Engineering and 3+ years of quality/validation experience, with strong RCA, DOE, and regulatory knowledge.

Qualifications

• BS in Engineering or related field required.
• 3+ years Quality/Validation experience.
• Experience with GMP/QA processes in medical device industry.

Responsibilities

• Execute and implement site validation initiatives for product design.
• Develop and maintain Validation Master Plan and tracking.
• Provide quality engineering guidance using RCA, FMEA, DOE and process improvements.
• Ensure GMP/ISO 13485 and 21 CFR 820 compliance; support audits.
• Lead change control and continuous improvement initiatives.

Skills

Statistical analysis

Root cause analysis

Quality engineering

Minitab

Regulatory knowledge

Education

BS in Engineering

Tools

Minitab

MS Word

Excel

MS Project

Job description

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, anda commitmentto improving lives, we are expanding our portfolio of solutions to serve even morepatients, healthcare providers, and communities around the world.

SUMMARY JOB DESCRIPTION:

The Site Validation Engineer is responsible for execution and implementation of validation initiatives in support of product design activities, maintenance of the site validation process, cross functional support for the Quality Engineering and Quality Systems group.

RESPONSIBILITIES:

• Responsible for validation and GMP/Compliance Training within the plant in conjunction with the Quality Systems and Quality Engineering Leaders.
• Develop and maintain the Validation Master Plan and validation tracking schedule.
• Provide critical quality engineering direction with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans.
• 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.
• Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.
• Lead and support quality engineering activities associated with change control, continuous improvement, and process optimization initiatives by ensuring appropriate risk assessments, validation requirements, product and process impact assessments, and effectiveness monitoring are completed in accordance with established quality system procedures.
• Identify, prioritize, and support continuous improvement opportunities by analyzing quality, manufacturing, and customer feedback data to drive sustainable process and product improvements.
• 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. Make basic procedural updates.
• Is an extended team member representing Site Quality on product development projects and a team member for sustaining engineering projects.
• Establishes a strong working relationship with all levels of operations to appropriately monitor and analyze in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control, and customer complaint levels to take a lead role in identifying and documenting continuous improvement projects.

EXPERIENCE & EDUCATION:

• Four-year college Bachelor of Science degree required. Bachelor of Science degree in Engineering desired.
• 3+ Years Quality experience including Validation and Quality Engineering responsibilities.

KNOWLEDGE, SKILLS AND ABILITIES:

• 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 Desired
• American Society of Quality (ASQ) certificate for CQE Desired
• 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.