Current Opportunities

Tracking # 50 Industry Pharmaceutical Jobs Job Title Sr Manager Validation Location Raleigh, NC Salary Open Job Description Overall responsibility for the management and execution of commercial validation and qualification projects for the site to assure on time delivery of product launches compliance with cGMP and process and system improvements. Working in tandem with the Manager of Process Optimization, the chosen candidate will assure that product/process technical transfer, including validation of manufacturing and cleaning processes occurs seamlessly. In addition the position will be expected to develop systems and processes to support cGMP compliance; assist in the identification and evaluation of critical processing parameters as relevant for the validation activities and provide product and process support through troubleshooting and investigation assistance to the shop floor. This will involve oversight of a team that will: conduct studies; write protocols and reports in support of process and cleaning validation; identify process improvements and design experiments to support and implement improvements while ensuring compliance with all Sandoz’s cGMP, SOP’s, FDA, HS&E and DEA regulations. RESPONSIBILITIES •Provides managerial oversight to the assigned team of validation personnel (as well as outside contractors or vendors) to direct compliant design of process validation protocols, cleaning validation protocols, and reports to meet targeted timelines. •Must possess a solid understanding of FDA validation and qualification guidelines and industry best practice for this field and be able to implement these standards on a daily basis. •Assignments are objective based and may require position to design best process/practice to meet objective. •Works in tandem with the Manager of Process Optimization and/or Research and Development to effectively plan and manage product launch or transfer activities. •Performs studies to qualify and validate alternate sources of critical raw materials and API’s. •Provides product and process troubleshooting and technical expertise to the shop floor to improve efficiency, reduce throughput, assist in product investigations and implementation of effective corrective actions throughout a product's lifecycle. •Develops written SOP’s and procedures for applicable areas of responsibility. •Develops an efficient and compliant team culture that is learning and continuous improvement focused to meet business needs. •Ensures projects are on schedule and within budget and performed in accordance with all company and industry regulations and procedures. •Assists in the preparation of the departmental budget and assures spending is monitored and maintained within guidelines. 10 years of experience in the fields of pharmaceutical manufacturing, technical support and/or product/process development along with an in-depth knowledge of industry process and cleaning validation and qualification techniques, cGMP , FDA and DEA regulations and recent trends in validation concepts. Must have hands-on knowledge of pharmaceutical equipment, and be able to supervise batch manufacture and instruct production operators. Must have a thorough knowledge of pharmaceutical unit operations and demonstrated ability to build teams that deliver. BS degree required 8 - 12 years of related experience BS or MS in a physical science Relocation Package Yes Interview Expenses Yes Benefits Package Yes