• Sterility Assurance Validation Associate II Jobs in United States Of America

  • Baxter India Pvt Ltd
  • United States Of America, Usa

Job Description:

The Sterility Assurance Validation Associate II supports the manufacturing facility through the qualification and/or validation of equipment and manufacturing processes Validation activities include protocol writing / execution and final report generation This position reports to the Sr Manager, Technical Services Validation

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned)

Performs same duties as an Associate I, however with deeper understanding of aseptic processing validation and impact on manufacturing processes Solves higher complexity problems and project challenges
Create and own variety of GMP documents that will be reviewed by regulatory auditors and clients (validation SOPs, Forms, summaries, Tech Services Study protocols, manufacturing procedures, batch record steps, investigations and corrective / preventive actions)
Represents SAV department in client and regulatory audits and provides responses to audit observations
Utilize various computer programs to accomplish validation activities and record information (Kaye software, Ellab software, MS excel, MS word, Qumas, Trackwise), and equipment specific programming for each of the various pieces of manufacturing equipment
Serves as the lead team member for validating new projects on new technologies and equipment
Conducts development studies on critical equipment Participates in or creates design of aseptic processes
Mentors and provides leadership to junior team members
Facilitate organization and participate in the performance of HEPA filter certification
Subject matter expert for operation and equipment specific programming of select critical equipment
Performs non-conformance (NCR) investigations, CAPA initiator & owner, and Change Control Management (CCM) initiator & owner
Serve as the line owner for one or more manufacturing lines Conduct gap assessments for new client projects vs existing validations to determine any new work required
Manage and serve as validation lead for onboarding new client projects
Plan media fill interventions, serve as department representative for the media fill, and summarize the results
Perform risk assessments of interventions and aseptic processing steps
Review and approval of master batch records (MBR) and bill of materials (BOM)


Bachelors degree required, preferably in a science or technical area
Minimum of 3 years related experience
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include JDE, BPLM, Pilgrim, Trackwise, etc)
Self-directed with high initiative and ownership
Critical & creative thinking, and problem solving skills a must
Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data

Physical / Safety Requirements

Ability to meet Grade A and B gowning requirements
Ability to lift 50 lbs
Must be able to climb and work from ladders
Must be able to qualify for 20/25 corrected vision
Duties will require overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment is required
Position requires standing for long hours, but may involve walking or sitting for periods of time

Equal Employment Opportunity

Baxter is an equal opportunity employer Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic

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Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTAbaxtercom and let us know the nature of your request along with your contact information

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare
Functional Area : HR/PM/IR/Training
Role : Recruitment
Salary : As per Industry Standards
Deadline : 19th Feb 2020

Key Skills:

Company Profile:

Baxter India Pvt Ltdarfix

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