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Essential Duties & Responsibilities

Support to establish and implement the validation program for all Baxter operations , facilities, utilities, equipment and process based on current industry practices and FDA guidelines.

Maintain validation program to comply with current FDA regulations. 

Provide validation requirements and training to plant personnel, contractors and vendors for processes, facilities, utilities  systems and equipment from GMP and validation viewpoint.

Assure validation approach is uniform and in conformance with company policies and FDA guidelines. 

Plan and coordinate validation activities. Provide documented evidence of validated submissions, equipment, control systems and manufacturing processes.

Prepare reports when required to include all relevant items within areas of responsibility. 

Present and defend to FDA (and all other regulatory bodies) validation protocols, results and documentation. 

Clear understanding of company validation approach.

Highly analytical and able to learn quickly of the process and from process equipment. 

Capable of understanding engineering diagrams and equipment manuals. 

Recommend approach to validation for all processes within the site. 

Requirements for revalidation for all processes within the site. 

Requirements

Language: Full Bilingual - written and spoken English & Spanish

Regulations: Basic cGMP knowledge, Knowledge of sampling techniques, knowledge of statistical software and calculations

Technical Qualification & Other Background

Computer literate (Word, Excel, Power Point)

IT or Computerized System Knowledge

Strong Analytical and problem solving skills

Technical writing & reporting skills

Knowledgeable on process and equipment validations

Good record keeping skills

Ability to work rotating shifts, weekends and holidays

Able to interpret and apply maintenance, repair, inspection and compliance codes or standards

Able to interpret and convert units of measure such as temperature, pressure, flow, area, mass, distance, volume or other.

Mathematical reasoning: add, subtract, multiply, divide and calculate percentages as well as able to use a calculator or other associated electronic equipment

Ability to follow written procedures and/or verbal instructions communications by telephone, fax, etc.

Specific Required Competencies

Functional/technical skills, Problem solving, Negotiation skills, Planning & Project Management

Education

Bachelor Degree in Engineering (Preferred, Mechanical, Chemical or Industrial)

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.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement

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_TTA@baxter.com and let us know the nature of your request along with your contact information.