Specialist II, Validation

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POST DATE 9/15/2016
END DATE 10/12/2016

Seqirus Holly Springs, NC

Holly Springs, NC
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Purpose:

Provides qualification lifecycle of equipment utilizing an integrated commissioning and qualification approach. Provides support of validation programs such as cleaning, shipping, computer systems and aseptic.

Major Accountabilities:

* Utilizes SOPs to develop validation protocols and summary reports.

* Data analysis skills that include the use of intermediate statistical analysis tools and interpretation of results vs. Acceptance criteria and regulatory guidance.

* Hands on field execution and collection of samples in support of validation studies.

* Programs and calibrates GE Kaye Validator units for use in validation studies. May serve as Kaye administrator.

* Coordination of validation activities with the appropriate system owners and other affected departments. Integration of validation maintenance activities into integrated site schedules. Owns CAPAs

* Leads simple deviation investigation utilizing root cause analysis and investigation tools. Owns CAPAs resulting from other site deviations.

* Provides training to new team members.

* Independently qualifies multiple types of GMP systems (i.e., utilities, cell culture and purification equipment, lab instruments, computer systems, filling and packaging systems), and validates sterilization and cleaning processes.

Minimum Requirements:

* Bachelor s degree in Engineering or related field required.

* 3+ years hands-on commissioning, qualification and/or validation experience OR equivalent required.

* 2+ years pharmaceutical manufacturing related experience preferred.

* Previous experience with an integrated qualification approach preferred.

Seqirus is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.