PharmaSys, Inc., a compliance services organization, provides validation, compliance and quality assurance services to the pharmaceutical, biotech, clinical trial and medical device industries. PharmaSys offers a wide range of services including serialization, computer validation, audit services, compliance training, commission, equipment/process validation, cleaning validation, and QA consulting.
Currently seeking a Validation Consultant
PharmaSys, Inc., a respected biopharmaceutical compliance consulting company local to the Research Triangle Park area of North Carolina, is seeking intelligent, motivated people with an 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. Entry level candidates are welcome.
To be successful with PharmaSys you must be able to work in a dynamic environment and have strong adaptability skills. PharmaSys consultants must be able to seamlessly transition from one project to the next, easily integrate into ever-changing work environments and be able to manage multiple projects. PharmaSys is a customer-centric company. Our consultants must be flexible and open to working on all types of compliance, validation and related projects.
Please review the responsibilities and requirements below to see if you are a match for our opening.
Key Responsibilities:
1. Plan, execute and manage commissioning, qualification and validation projects in the biopharmaceutical, medical device and clinical trial industries using good FDA and EMA practice.
2. Work with and coordinate commissioning, qualification and validation related activities with production, engineering, maintenance, QA or others, including outside contractors, during validation projects.
3. 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, laboratory equipment, utilities, process equipment, automation systems and computer systems.
4. Generate protocols, execute testing and generate summary reports for process validation (PV) and cleaning validation (CV).
5. Preparation, programming, maintaining, and use of data acquisition systems used for validation of plant equipment.
6. Continuously improve and update the validation program.
Key Requirements:
1. B.S. degree in engineering or a scientific discipline, engineering preferred.
2. Hands-on experience in validation/qualification of pharmaceutical equipment, computer systems and processes is preferred. Entry level candidates with internship or co-op validation and related experience will also be strongly considered.
3. Experience in an FDA or ISO regulated environment is highly preferred, as well as familiarity with cGMP regulations and Quality Assurance operations.
4. Technical background encompassing engineering, instrumentation, programmable logic controllers, biology, chemistry, and statistics is desirable.
5. A high level of interaction with client is expected; therefore, strong oral and written communication skills are required. Professionalism is a must!
6. Strong communication skills and superior technical/scientific writing capabilities.
7. 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.
8. Advanced computer skills (Microsoft Word, Excel and Access – or equivalent)
9. Ability to travel to client sites as required. Being a customer-centric company requires PharmaSys to go where the clients need us to. Travel needs are project specific.
10. Prefer candidates local to Raleigh, NC area - relocation benefits are not available.
11. Candidates must be authorized to work in the United States without the need for sponsorship either now or in the future.
PharmaSys is looking for regular, full-time employees and will consider those applicants first. Independent contractors (1099) will be considered on an as-needed basis. Please submit a copy of your current resume and desired rate of pay.
To learn more about PharmaSys, please go to www.pharma-sys.com.