- Establishes validation standards, develops and executes validation protocols, reports on findings, and oversees resolution of compliance failures or deviation.
- Develops and maintains validation-related documentation, which may include specifications, SOPs, work instructions, or batch or testing records.
- Ensures processes, products, equipment, or systems comply with all applicable external regulations or standards.
- May assist with new equipment purchases or upgrades to existing equipment.
- May require execution of FATs, SATs, CTPs, IQ's, OQ's, PQ's, PVs and other validation life cycle documents.
- Document development and field execution of test protocols.
- Grow and maintain solid client relationships.
- Perform investigations and troubleshoot issues related to validation.
- Develop validation plans.
- Minimum 5years of demonstrated experience with validation of pharmaceutical or medical device processes and equipment
- FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the Pharmaceutical Industry
- Validation experience in the areas of automation, packaging, cleaning, computer systems, utilities and/or facilities is desired.
- Candidates need to possess good communication and interpersonal skills and the ability to interact with all levels of management, clients, and vendors. Strong computer skills are also required.
- BS Mechanical Engineering or ElectricalEngineering
- Up to 50% regional travel is required.