Careers
Automated Systems, Inc. (ASI) was established in 1989. We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. ASI specializes in serving the needs of the pharmaceutical, biotech, and medical device industries. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.
Open Positions
Validation Specialist
In this position, you will be responsible for development, execution & analysis of validation projects to demonstrate facility, equipment and process consistency and cGMP compliance within the Active Pharmaceutical Ingredient (bulk pharmaceutical chemicals) processing areas. You will also collaborate with internal and external technical and management personnel to establish project priorities, goals, structure and optimization of validation approaches. Other duties include providing validation project management associated with new or modified facilities; acting as interface between various functional areas (internal and external) to assure successful integration and completion of validation activities in overall project schedules; and providing divisional guidance and support in all areas of facilities, equipment, process and cleaning validation.
To qualify, you must have a BS in Engineering or Life Sciences, and at least 1 year of validation, and/or technical engineering science experience in API manufacturing environment. You must have a good working knowledge of manufacturing/engineering disciplines with established project management skills across multiple functional areas. Knowledge of fundamental cGMP concepts is highly desirable.
Computer Validation Specialist
This is a full-time project oriented computer validation position for a senior hands-on person familiar with IQ/OQ/PQ protocols, SOPs, laboratory systems, 21 CFR Part 11, FDA regulations. The ideal candidate will have several years of pharmaceutical industry experience, lab preferred. The candidate will also have computer validation and testing experience. The candidate should have extensive knowledge of computer systems plus working knowledge of quality practices and FDA regulations. Must have excellent command of the English language, both oral and written and enjoy detailed work.
To qualify, you must have a BS in Engineering or Life Sciences, and at least 2 year of validation, and/or technical engineering science experience in a cGMP environment.
Instrumentation and Controls Engineer
In this role, you will support the design, installation and startup of process controls as part of an automation group. You will work with engineering teams to implement controls for pharmaceutical manufacturing systems; develop P&I diagrams, controls strategies and process operating descriptions; specify instrumentation; and generate design documents and specifications for hardware and software based on user requirements. Other responsibilities include documenting/meeting compliance requirements, acting as project manager for the process automation portion of capital projects, and managing vendors, A&E firms, system integrators and contract engineers to assure completion of work on schedule and within budget. You will also assist the field startup/qualification of process control systems and provide troubleshooting support as needed for existing systems.
Qualifications include a minimum of a BS in Chemical, Mechanical or Electrical engineering, as well as 5-15 years of experience with process controls. Substantial experience in PLC and SCADA applications in a pharmaceutical or food environment is strongly preferred. You should have an understanding of configuration, programming and startup of PLC's. Ideal candidates will also have the ability to develop database and graphics interface for SCADA systems, working knowledge of field wiring practices and panel design, experience with troubleshooting and startup of control systems, and familiarity with sanitary valves and instrumentation. Knowledge of pharmaceutical equipment is a plus. Excellent oral and written communication skills are also required.
Qualified candidates should contact ASI via email.
humanresources@automatedsys.com
|
|
