Compliance Team, Inc. is a leading provider of quality technical consulting services and resources to our strategic partners in the pharmaceutical, biotechnology, and medical device industries. Whether we are asked to provide an entire team or an individual, our professionals consistently provide quality oversight of operations, review for accuracy, completeness, and conformance to current good manufacturing practices (cGMP), company quality standards, and regulatory compliance. We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects.
Become part of our team. We have exciting opportunities for Validation Engineers. We seek top-notch professionals with project management experience to provide commissioning and validation services/reports for facility, process, utility systems and control systems in the bio-tech, pharmaceutical and/or medical device industry.
We have multiple validation projects beginning soon and require Validation Engineers with various degrees of experience. The successful candidate will perform IQ/OQ and cleaning validation at an aseptic pharmaceutical manufacturing facility.
Desired Skills and Experience:
The following listed requirements need to be met at a minimum:
Bachelor degree in Engineering, Science, or Computer Science
5 – 10 years of industry experience
Previous project management experience
Familiarity with commissioning and validation concepts, procedures, protocols and requirements
Knowledge of FDA regulations and pharmaceutical and or medical device GMP's
Familiarity with the pharmaceutical/medical device manufacturing process, facilities and equipment, calibration, and IQ, OQ, PQ requirements
The skills listed below are desired in the ideal candidate:
Exercises a high degree of initiative, judgment, discretion and decision making to integrate organizational priorities, meet deadlines, and achieve objectives.
Has a track record of managing projects to completion on time and within budget.
Strong ability to resolve problems, to prioritize solutions, to determine appropriate course of action, gain consensus on that recommendation, and to implement the decision.
Leadership skills to perform as a leader of cross-functional work teams.
Confidently interacts with peers, vendors, various personnel in scientific, engineering, QA, Validation, and operational disciplines.
Has excellent analytical and problem solving skills.
Detailed oriented, well-organized and ability to prioritize and meet deadlines
Excellent oral and written communication skills
Excellent organizational and time management skills
Strong decision making and creative problem solving skills
Ability to develop, organize, and manage multiple tasks
The successful candidate should demonstrate integrity, reliability, dedication, adaptability, innovation, and self-motivation.