If you would enjoy supporting a broad and diverse range of products from a Quality perspective, this may be your opportunity! In this role, you will have dual responsibilities, performing both Quality Engineering and Validation work. From the Quality Engineering side, you will partner with Manufacturing and Engineering to investigate quality issues, root cause and corrective actions. You will also support quality improvement initiatives.
You will also support the Validation function within your plants, ensuring manufacturing processes and equipment are operating in a validated state, on a consistent and reliable basis. Although this role with be responsible for both Quality Engineering and Validation, the initial focus of the role will be in supporting critical projects for validation, and it will be essential for you to come in and hit the ground running.
This is a very collaborative environment, that will have you working broadly with cross functional teams to strengthen quality assurance capabilities. If you would enjoy a highly visible role that positions you as a quality expert in the limelight of high functioning plants, take a look at this opportunity!
What skills and background will be important to be successful:
- At least 6 years of experience in a cGMP or FDA regulated manufacturing environment
- Prior Quality Engineering and Validation experience
- Experience with IQ, OQ, and PQ
- Background in root cause analysis, OOS investigations, and CAPA
- Experience with ETQ is a plus
- Strong interpersonal and communication skills with the ability to influence
- Bachelor of Science or Engineering or Life Sciences degree required