Sr. Validation Engineer

Sr. Validation Engineer
Company:

(Confidential)


Sr. Validation Engineer

Details of the offer

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed:to protect life.

I. JOB SUMMARY

Development and execution of the site validation program including initial installation and operational qualification of equipment for manufacturing processes and laboratory equipment and subsequent validation maintenance that supports both project and site revalidation timeline.

II. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

:

Develop project equipment qualification strategies and schedules using risk based approach to ensure both compliance to desired validation state and speed.
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Coordinate and perform qualification and validation activities for equipment, laboratory instruments and steam sterilization validation activities.
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Perform qualification work on sterilization equipment.
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Perform qualification work on controlled temperature units.
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Write validation protocols and final reports summarizing qualification work.
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Review and approval of validation protocols and reports
:

Performs other duties as assigned

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects managements assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education

:
B.S. in Engineering or closely related scientific field.

Experience

:
3:5 years of experience in the following:
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GxP procedures and guidelines
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Good Documentation Practices
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Authoring qualification protocols and reports
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Review and approval of validation protocols and reports
Preferred Experience

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Experience using Kaye Validator equipment for temperature mapping studies
Skills

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Basic skills and fluency in Microsoft Word, Visio, Outlook and Excel
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Strong technical writing skills
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Strong oral and written communication skills
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Ability to collaborate with functional teams
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Project planning

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non:solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioS


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Area:

Requirements


Knowledges:

  • Basic

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