Specialist II/III,

4 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**

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