Commissioning and Validation Engineers

 Compliance Team, Inc. has exciting opportunities for Commissioning and Validation Engineers in various locations.  We seek top-notch professionals who have a diverse commissioning and/or validation experience with facility, process, and utility systems and control systems in the biotech, pharmaceutical and/or medical device industry.

 

Responsibilities: The responsibilities include preparing commissioning and qualification protocols and executing commissioning plans, IQ, OQ, and PQ activities for plant equipment, facilities, utilities, process control systems, computer systems, cleaning validation, and process validation projects for our clients in support of GMP / FDA requirements.

 

Requirements/Qualifications

· Bachelors degree in Engineering, Science, or Computer Science

· 2-5 years experience in FDA related manufacturing or laboratory operations

· Familiarity with commissioning and validation concepts, procedures, protocols and requirements

· Knowledge of FDA regulations, pharmaceutical GMPs (21 CFR 210 and 211)

·   Familiar with pharmaceutical manufacturing process, facilities and equipment, calibration, IQ, OQ, PQ, and development of SOPs

· Experience with process control applications is desirable

·   Excellent organizational and time management skills

· Excellent decision making and creative problem solving skills

· Ability to develop, organize, and manage multiple tasks

 

In addition to the above technical competencies, ideal candidates will have a commitment to delivering quality documents and service excellence along with outstanding interpersonal, oral, and written communication skills.  Candidates must be results-oriented, able to make decisions, and able to prioritize work per business needs.  Strong communication, organization, and time management skills are necessary.  Desired skills include: teamwork, leadership, ability to maintain constructive relationships with personnel from various disciplines at all levels in the organization.  The successful candidate should demonstrate integrity, reliability, dedication, adaptability, innovation, and self-motivation.

 

  For more company information see: http://www.complianceteaminc.com/