Job: Validation Consultant, PharmaSys, Inc., Cary, NC
PharmaSys, Inc., a respected biopharmaceutical compliance consulting company local to the RTP area, is growing and seeking experienced, motivated people with entrepreneurial spirit to join our winning team. Successful applicants will provide technical and validation support services to a variety of biotech, medical device, pharmaceutical, and clinical companies.
Please review the responsibilities and requirements below to see if you are a match for our opening. Only qualified candidates will be considered.
• Plan, execute and manage commissioning, qualification and validation projects in the biopharmaceutical, medical device and clinical trial industries using good FDA and EMA practice.
• Work with and coordinate commissioning, qualification and validation related activities with production, engineering, maintenance, QA or others, including outside contractors, during validation projects.
• Generate protocols, execute testing and generate summary reports for validation plans, commissioning plans, installation qualification (IQ), operational qualification (OQ) protocols and performance qualification (PQ) for facilities, utilities, process equipment, automation systems and computer systems.
• Generate protocols, execute testing and generate summary reports for process validation (PV) and cleaning validation (CV).
• Preparation, programming, maintaining, and use of data acquisition systems used for validation of plant equipment.
• Continuously improve and update the validation program.
• B.S. degree in engineering or a scientific discipline, engineering preferred.
• Three to five years hands on experience in validation/qualification of pharmaceutical equipment, computer systems and processes.
• Experience in an FDA or ISO regulated environment is highly preferred, as well as familiarity with cGMP regulations and Quality Assurance operations.
• Technical background encompassing engineering, instrumentation, programmable logic controllers, biology, chemistry, and statistics is desirable.
• Project management experience is a plus
• A high level of interaction with client is expected; therefore strong oral and written communication skills are required. Professionalism is a must!
• Strong communication skills and superior technical/scientific writing capabilities.
• Ability to interact with clients, vendors, and basic leadership skills with other consultants and contractors in a professional setting, while applying sound analytical thinking and judgment to resolve complex technical problems in a timely manner.
• Advanced computer skills (Microsoft Word, Excel and Access – or equivalent)
• Ability to travel to client sites is required. PharmaSys is a customer focused business and we need to have consultants who are able to travel to customer sites as projects require.
• Prefer candidates local to Raleigh, NC area - relocation benefits are not available.
Please provide a detailed resume that highlights your experience that is relevant to this job. We are looking to hire the right candidate ASAP. A Bachelor's degree is required in order to be considered for this position. Qualified candidates will be asked to submit a professional writing sample during the recruiting process.