Validation Engineer II

Oxoid Remel Microbiology; Lenexa (KS); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

401k

Healthcare coverage

Vision coverage

Employee assistance program

Telehealth/24-7 virtual doctor visits

Job summary

Oxoid Remel Microbiology, part of a 100-year microbiology legacy, seeks a validation professional to qualify culture media and related diagnostic products. You will ensure compliance with 21CFR 820, ISO 13485, and drive investigations for abnormal results within a cross-functional quality team.

We offer extensive training, growth opportunities, and benefits including 401k, healthcare, vision coverage, and 24/7 virtual doctor visits.

Qualifications

• Bachelor's degree in a science, engineering, or related field.
• Preferred 1 year of Validation experience in a regulated environment.
• Preferred experience with lean manufacturing tools and practices.

Responsibilities

• Execute Validation studies in compliance with 21CFR part 820, ISO 13485, and other medical device industry standards.
• Set, incubate, and read microbial media test results. (Including bacterial indicators, media fills, and utilities)
• Support investigations when abnormal results are found.
• Write reports to support qualification of new equipment and requalification.
• Support continuous improvement activities and the transition to a Lean Manufacturing Environment.

Skills

Data analysis

Cross-functional teamwork

Prioritization

Problem solving

Excel

Education

Bachelor's degree in science/engineering

Tools

Minitab

Job description

Joining our team, you'll play an active part in helping to deliver meaningful impact. At Oxoid Remel Microbiology, acquired from Thermo Fisher Scientific, we play a crucial role in accurate identification and targeted treatment for diseases, ensuring food and beverage safety, and supporting pharmaceutical manufacturing integrity. Our products and services are designed to meet the highest standards of quality and performance, helping our customers achieve their objectives efficiently and effectively.

Division/Location Specific Information

The Microbiology Division provides solutions and workflow for food, clinical, and pharmaceutical environments. The markets we serve include food manufactures and labs, clinical and healthcare, pharma, and biotech. Our Lenexa Site has over 300+ employees, it manufactures culture media and other microbiological diagnostic products serving customers in the pharmaceutical, food, and clinical laboratories.

DESCRIPTION

How will you make an impact?

As a part of the validation team, you will be responsible for the validation & qualification of culture media and other microbiological diagnostic products to ensure they meet customer regulatory requirements. This role provides the opportunity to grow within the quality team as a technical expert or people leader as well as other opportunities across the Oxoid Remel Microbiology organization. Extensive training and supplementary tertiary education support available to aid your growth in role. Benefits include 401k, healthcare and vision coverage, employee assistance program, 24/7 virtual doctor visits, back up children and eldercare, and more!

What will you do?

• Execute Validation studies in compliance with 21CFR part 820, ISO 13485, and other medical device industry standards.
• Set, incubate, and read microbial media test results. (Including bacterial indicators (BI), media fills, and utilities)
• Support investigations when abnormal results are found.
• Write reports to support qualification of new equipment and requalification.
• Support continuous improvement activities and the transition to a Lean Manufacturing Environment.

REQUIREMENTS

How will you get here?

• Bachelor's Degree in a science, engineering, or related field preferred.
• Preferred 1 year of Validation experience in a regulated environment
• Preferred experience with lean manufacturing tools and practices.

Knowledge, Skills, Abilities:

• Data analysis skills and ability to utilize computer programs to analyze data to drive decisions.
• Ability to prioritize multiple tasks and function effectively.
• Demonstrated ability to work effectively as a member of a cross-functional team.
• Strong working knowledge of various computer software, such as Excel, Mini-tab.
• Preferred working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments).
• Preferred background in Medical device, GMP, EU Regulation or ISO 13485.

This is an exciting time to join us as we continue to build on more than 100 years of microbiology excellence. With a broad portfolio of instruments, services, and global resources, we're steadfast in our commitment to helping you succeed. Together, we can cultivate a thriving microbiology culture that supports you today, tomorrow, and for life. Oxoid Remel Microbiology, acquired from Thermo Fisher Scientific, is now under the ownership of Astorg, a leading private equity firm with deep healthcare sector expertise and proven track record in diagnostics. With the continuity of trusted brands, established expertise and a long-standing reputation in microbiology, we're looking for talented people to join us as we enter our next chapter of growth. Come and be part of what's next for our company.

Oxoid Remel Microbiology is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Oxoid Remel Microbiology offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.