Validation Associate II

Baxter International Inc. • Round Lake, IL

4d • $80,000 - $110,000

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter Must not be allergic to Cephalosporins or Penicillin. This position is responsible for the development and the execution of projects which include engineering studies, validation protocols and re-validations of manufacturing facilities, equipment, utilities, computerized systems, cleaning methods, and processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA and client/customer compliance audits.

Requirements

• BS Degree in Science, Engineering or Math with 2 or more years of experience.
• Master's Degree with 1 or more years of experience.
• At least 2 years of direct experience with writing and executing validation protocols is preferred.
• Understand scientific strategies and be able to invent new methods or new avenues of investigation.
• Good interpersonal/communication/influencing/negotiation skills.
• Strong project management skills
• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
• Proficient in Microsoft Word and Excel, computer software.
• Ability to work independently or in teams.
• Physical demands of the position may require the ability to lift materials up to 20 lbs, dexterity to gown, mobility to maneuver around equipment, and enter into confined spaces.

Nice To Haves

• Some experience with statistical software helpful.
• Direct or indirect industry knowledge.

Responsibilities

• Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
• Schedule, plan, communicate, and manage documents and follow-up on validation activities.
• Interpret and apply regulatory requirements concerning validation activities.
• Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
• Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations.
• Review and generate quality documents including validation protocols, SOPs, change controls, and non conformance event records as required.
• Serves as a project lead for projects of intermediate scope with cross-functional teams.
• Support regulatory inspections and responses as required.
• Able to prioritize workload and tasks.
• Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations.

Benefits

• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level