Job Summary

Oversee sterility assurance personnel in cycle development, maintain compliance for all Medline sterilization requirements, oversee sterility releases, identify and qualify sterilization and laboratory vendors. Responsible for providing technical guidance and being a decision maker for ethylene oxide, steam, radiation and novel sterilization processes strategies.

Job Description

Responsibilities:

Lead validation sterilization process and optimize the current processes to reduce sterilization costs and increase capacity.
Review and approve sterilization protocols and reports.
Manage the development, maintenance, and validation of new process challenge devices for ethylene oxide sterilization cycles and conduct training for others.
Monitor AAMI/ISO standards and review changes to ensure sterilization validations compliance.
Review and revise Corporate Sterilization procedures to make sure they are in line with current practices and regulatory requirements.
Direct the internal, customer and regulatory audits and ensure that recommendations and corrective actions are appropriate and efficiently acted upon and documented.
Review and approve control system software upgrade and validation for in-house and overseas sterilization facilities.
Provide global support for FDA and ISO inspections related to sterilization activities.
Provide support for global technical equipment and validation efforts to include microbiological process qualifications, software validation, process performance qualifications and equipment troubleshooting.

Management responsibilities include:

Typically, manages through multiple Managers and/or Supervisors
Oversee major projects/programs/outcomes;
Budget responsibility; interpret and execute policies for departments/projects and developments
Recommend and implement new policies or modifications to existing policies
Provide general guidelines and parameters for staff functioning
Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

Qualifications:

Bachelor’s degree with a scientific or engineering background.
Member of AAMI sterilization working group.
At least 5 years of sterilization experience with ethylene oxide and radiation processes.
At least 2 years of experience directly managing people including hiring, developing, motivating, and directing people as they work.
Experience in learning and assimilating new information for both current and future problem solving and decision making.
Skill and ability to diagnose, isolate, and resolve complex issues and recommend and implement strategies to resolve problems.
Demonstrated ability to influence, lead and direct individuals in multiple functional areas.
Demonstrated ability of controlling and coordinating concurrent projects, competing priorities and critical deadlines.
Position requires travel up to 15% of the time for business purposes (domestic and international).
Position requires work in environments where hazardous chemicals may be encountered.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$132,600.00 - $199,160.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page here.

Medline Industries, LP is an equal opportunity employer. Medline 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.

Responsibilities:

Lead validation sterilization process and optimize the current processes to reduce sterilization costs and increase capacity.

Review and approve sterilization protocols and reports.

Manage the development, maintenance, and validation of new process challenge devices for ethylene oxide sterilization cycles and conduct training for others.

Monitor AAMI/ISO standards and review changes to ensure sterilization validations compliance.

Review and revise Corporate Sterilization procedures to make sure they are in line with current practices and regulatory requirements.

Direct the internal, customer and regulatory audits and ensure that recommendations and corrective actions are appropriate and efficiently acted upon and documented.

Review and approve control system software upgrade and validation for in-house and overseas sterilization facilities.

Provide global support for FDA and ISO inspections related to sterilization activities.

Provide support for global technical equipment and validation efforts to include microbiological process qualifications, software validation, process performance qualifications and equipment troubleshooting.

Management responsibilities include:

Typically, manages through multiple Managers and/or Supervisors

Oversee major projects/programs/outcomes;

Budget responsibility; interpret and execute policies for departments/projects and developments

Recommend and implement new policies or modifications to existing policies

Provide general guidelines and parameters for staff functioning

Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

Qualifications:

Bachelor’s degree with a scientific or engineering background.

Member of AAMI sterilization working group.

At least 5 years of sterilization experience with ethylene oxide and radiation processes.

At least 2 years of experience directly managing people including hiring, developing, motivating, and directing people as they work.

Experience in learning and assimilating new information for both current and future problem solving and decision making.

Skill and ability to diagnose, isolate, and resolve complex issues and recommend and implement strategies to resolve problems.

Demonstrated ability to influence, lead and direct individuals in multiple functional areas.

Demonstrated ability of controlling and coordinating concurrent projects, competing priorities and critical deadlines.

Position requires travel up to 15% of the time for business purposes (domestic and international).

Position requires work in environments where hazardous chemicals may be encountered.