Validation Associate II

Baxter International Inc.•Round Lake, IL

1d•Onsite

About The Position

At Baxter, the mission is to save and sustain lives by redefining healthcare delivery. The company fosters a culture of courage, trust, and collaboration, empowering individuals to make a meaningful impact and deliver exceptional results. This position is responsible for the development and execution of projects including engineering studies, validation protocols, and re-validations of manufacturing facilities, equipment, utilities, computerized systems, cleaning methods, and processes. Validation activities encompass research, protocol writing/execution, and final report generation. Additionally, the role involves investigating manufacturing challenges and evaluating/implementing process improvements. Final documents are archived and may support A/NDA submissions, as well as being available for FDA and client/customer compliance audits. Applicants must not be allergic to Cephalosporins or Penicillin.

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.
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.
Direct or indirect industry knowledge.
Ability to work independently or in teams.
Must not be allergic to Cephalosporins or Penicillin.
Ability to work at least 5 days onsite.

Nice To Haves

At least 2 years of direct experience with writing and executing validation protocols is preferred.
Some experience with statistical software helpful.

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

comprehensive compensation and benefits packages
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
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
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits