1. Facility and Utilities Validation Programs: Oversees and executed facility and Utilities validation activities in Operations settings, Continually analyzes environmental and/or utility monitoring data from the manufacturing areas for purposes of remediation of any developing trends.

2. Equipment and Process Validation: Collects and can interpret critical process and equipment data in support of test protocol development, Understands and Develops process flow diagrams associated equipment operation and the manufacturing process.

3. Quality Systems Support: perform special projects as assigned as well as review relevant regulatory guidance in order to identify gaps within site programs and develop remediation strategy with functional leads.

1. Bachelor’s Degree and Above, Engineering, Microbiology, Chemistry, or a related degree with scientific, engineering, clinical or regulatory course of study optimal.

2. 3-5 years minimum experience, experience in facility, utility, equipment IQ, OQ, PQ and PV.

3. Medical devices – Validation and routine control of devices ,CFR Part 820, and or knowledge of 210/211 ISO 13485.

4. Innovative – Looks for new and innovative approaches. Ability to think strategically and to plan. creatively to accelerate project timelines.