We're looking for a Logistics Validation Engineer or Specialist to join our team and help manage and support validation records related to shipping and logistics. You'll be responsible for creating and maintaining documents like Operational Qualifications (OQ) and Performance Qualifications (PQ), as well as helping close out quality records in our electronic quality management system (eQMS)—things like change controls, deviations, CAPAs, and action items.
What You'll Be Doing:
As a key member of the Logistics Validation team, you'll juggle multiple studies and quality records, making sure everything stays on track and meets regulatory expectations. You'll coordinate or lead activities across studies, keep an eye on timelines, and ensure the quality of records is solid and technically sound.
Day-to-Day Responsibilities:
- Help create and execute validation studies (protocols, execution, reporting) for new product launches and updates.
- Support timely and accurate completion of deviations, including closing them out by due dates.
- Work with other teams to hand off CAPAs smoothly and make sure they're implemented on time.
- Use a mix of soft skills and technical know-how to drive deviation and CAPA processes—teamwork, writing, communication, and vendor coordination are key.
- Collaborate with teams across Quality, Process Dev, Regulatory, MSAT, Commercial, and Supply Chain.
- Jump in on other supply chain validation projects when needed.
What You Bring:
- Great communication and follow-up skills to keep deadlines on track and prevent overdue records.
- Working knowledge of GMP/GDP, especially as it relates to digital records.
- Basic understanding of supply chain logistics.
- Experience writing and working with GxP docs like SOPs and work instructions.
- Familiarity with validation principles and experience running validation studies in a regulated setting.
- Strong organizational and multitasking skills.
- A bachelor's degree in a scientific or health-related field.
- Around 4 years of relevant experience—or a mix of education and hands-on work that adds up.