Specialist II/III, - Holly Springs, United States - Seqirus U.S.A. Inc.

Description

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 **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.

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**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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