- Executes analytical methods, including total organic carbon (TOC) and conductivity, to meet required timelines to support cleaning validation and cleaning verification testing conducted in support of GMP clinical manufacturing for a pilot plant.
- Executes analytical methods, including cleanability and recovery testing, to analyze new materials that are introduced into the global supply network, including buffers, process intermediates, and final product samples. This soil characterization testing is performed in support of clinical and commercial sites across the client's global network.
- Performs all analytical testing in a timely and efficient manner to support various project timelines.
- Various functions to keep the laboratory in a GMP state, including author/ownership of applicable standard operating procedures (SOPs), coordinating calibration activities, and detailing all testing activities in the appropriate electronic notebook.
- Performs all work with good documentation practices (GDP).
- Ensures that all laboratory equipment remains in a proper GMP state including the coordination of calibration work and maintenance activities and maintain supply inventory
- Initiates and prepares change management documentation for deviations and document all Obvious Laboratory Error - Observations
- Practices highest regard for safety
- Act as a subject matter expert (SME) for the analytical methods employed by the laboratory
- Possess ability to answer analytical questions and interact with internal auditors
- B.S. / B.A. in an Engineering or Science discipline with 1 to 3 years of relevant experience in a GMP laboratory or pharmaceutical validation discipline
- Strong interpersonal skills and problem-solving ability
- Demonstrated leadership and teamwork skills, excellent analytical abilities, excellent written and verbal communication skills
- Performing total organic carbon (TOC) or conductivity analysis
- GxP level technical writing
- Knowledge of cleaning validation and cleaning verification
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Validation Engineer - Horsham, United States - PAREXEL
Description
We are looking to fill a position for a Validation Engineer - Laboratory working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off.
Responsibilities:
Qualifications:
Required Skills and Experience:
Desired Skills and Experience:
About Parexel
Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.
Come join us
