Specialist II/III,

2 weeks ago

Holly Springs, United States Seqirus U.S.A. Inc. Full time

Specialist II/III, (Validation) - Cleaning page is loaded **Specialist II/III, (Validation) - Cleaning** **Specialist II/III, (Validation) - Cleaning** locationsSeqirus USA - NC - Holly Springs

time typeFull time

posted onPosted Yesterday

job requisition idR-147968

**Job Purpose:** Provides validation lifecycle of processes including: Process validation, Aseptic validation, Cleaning validation, and Shipping validation. Provides support of equipment qualification as needed. ***Level will be determined by years of experience.** **Major Accountabilities:** * Provide technical input in one or more programs including Process Validation, Aseptic Validation, Cleaning Validation, and Shipping Validation: * Writing and executing validation plans, protocols, and writing summary reports, in accordance with approved procedures * Evaluation, implementation, and support of change controls and investigations * Active member of integrated team where interaction with various groups is required to coordinate, plan, and execute work including new facilities or complicated changes * Ensures that current industry standards are reviewed and implemented * Support regulatory filings * Maintenance of lifecycle documentation (e.g. validation plans) * Participation in regulatory inspections * Provide technical support to the Seqirus network and Contract Manufacturing Organizations (CMOs): * Provide technical support to Seqirus network sites * Oversight of tech transfer validation to CMOs * Participate in site and departmental objectives which may preclude scope of expertise. * Support equipment / automation validation in either QC, facilities, fill finish, or bulk manufacturing * Build and maintain relationships with stakeholders including Operations, MS&T, and Quality. **** **Minimum Qualifications:** * Bachelors degree is required in Engineering, technical or science related field. * Minimum of 5 years of direct validation experience in one or more of the following validation programs: **process, aseptic, cleaning, and shipping.** * Previous experience using an integrated qualification approach required. * Program ownership and/or interaction with regulatory agencies preferred: * **Inspection defense** * **Authoring responses** * **Strategy building in partnership with Regulatory Affairs** * Provides input to business problems by sharing functional knowledge with others in own professional discipline * Travel may be required on occasion (minimal) ****Our Benefits**** Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the

you can participate in when you join Seqirus. ****About Seqirus**** Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about . ****We want Seqirus to reflect the world around us**** As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about

at Seqirus. ****Do work that matters at Seqirus**** **Watch our On the Front Line video to learn more about Seqirus** 0:00

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