What are the responsibilities and job description for the Senior Validation Engineer position at Masis Professional Group?
🚨 Senior Validation Engineer — Memphis, TN
⭐ US Citizens or Green Card holders only
💰 Pay: From $95,000 to $115,000
📍 On-site | ☀️ Day shift
🚫 No relocation assistance
🚫 No C2C
About the company
This site supports medical device manufacturers with the quality-critical work that happens after a product is built—helping ensure devices are clean, compliant, tested, and packaged correctly before they reach hospitals. The site focuses on GMP-driven operations such as cleanroom assembly, sterile/non-sterile packaging, inspection/testing support, and validation—making it a great environment for engineers who value precision, documentation, and patient safety.
Step into a highly visible validation role where your work sets the standard. You’ll lead and execute IQ/OQ/PQ for equipment and end-of-line processes, elevate documentation that operators actually use, and partner with Quality/Operations/R&D to keep manufacturing compliant, efficient, and audit-ready.
Job Duties
✅ Lead Equipment & Process Validation
- Execute and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment and end-of-line processes
- Ensure validation activities meet GMP, customer, and regulatory requirements
✅ Own Manufacturing Work Instructions
- Develop, update, and improve work instructions to reflect validated processes in production
- Partner with Operations and Quality to ensure instructions are clear, consistent, and effective
✅ Drive Cross-Functional Problem Solving
- Participate in investigations, root cause analysis, and corrective actions
- Collaborate with Quality, Manufacturing, and R&D on continuous improvement initiatives
✅ Customer-Facing Technical Support
- Serve as a technical liaison on validation topics, timelines, and deliverables
- Communicate clearly to align expectations and keep projects moving
✅ Train, Mentor, Deliver
- Train operations personnel on validated processes, work instructions, and equipment operation
- Mentor junior engineers/technicians as needed
- Lead moderate-scope projects (scope, schedule, coordination, execution) based on level
Job Requirements
- BS in Engineering required
- 4–8 years validation engineering experience in a GMP manufacturing environment
- Strong, hands-on experience with IQ/OQ/PQ
- Knowledge of GMP environments
- Strong technical writing (protocols, reports, work instructions)
- Strong communication, attention to detail, and problem-solving
- Ability to work independently and manage customer communications
Salary : $95,000 - $115,000