Process Validation Engineer - Full-time / Part-time

Position Summary:

As the Sr. Validation Engineer, you will be responsible for Process Validation and cleaning validation activities in the commercial manufacturing area. The incumbent will write and execute Validation master plans, protocols, and Validation reports and conduct product robustness of the commercial products assigned. The core work will include writing and owning documents such as protocols, reports, deviations, APR, MBR, CAPAs and memorandum required to ensure timely maintenance of commercial schedule and compliance.

• Responsible for designing, conducting and coordinating scientific studies for physical/chemical characterization and process development.
• Perform scale up development and optimization of manufacturing process based on regulatory guidelines related to pharmaceutical development (such as ICH Q8, Q9 & Q10).
• Collaborate with formulators and technicians regarding the design and execution of pilot and commercial process parameters, creation of formulation spread sheets, master batch record writing, batch execution, and post batch evaluation and analysis.
• Executes experiments at lab scale and commercial scale to implement the use of quality by design (QbD) principles and design of experiments (DOE) to develop robust process parameters. Design the experiments using statistical software is a plus.

Position Requirements:

• Bachelor's Degree in a Science field, Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related disciplines, with a minimum of 3+ years related experience and/or equivalent combination of education and experience in Pharmaceutical Development/Validation/ Manufacturing.
• Good understanding of pharmaceutical unit operations such as blending, milling, compression, tablet coating and encapsulation process.
• Second Shift: 11:30am-8:30pm

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Aerotek is acting as an Employment Agency in relation to this vacancy.