Senior Systems Engineer, Quality Facilities Validation Group

For Us, It's A MissionAt Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you. Make a DifferenceAt Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help:Provide oversight of standardized Quality Equipment Validation processes.Develop and enhance validation programs to reflect current, best practice regulatory expectations and support the business model and objectives for this facility. Provide oversight of the development and execution of qualification protocols for facility systems, manufacturing equipment, and laboratory instruments.  Provide oversight to development and validation of Excel spreadsheets.Review and approve computerized systems validation documentation such as risk assessments, user requirements, testing, validation plan/reports, etc.Support the change control program with respect to facility and equipment changes.  Support the Information Technology change control program for computerized systems.Ensure audit readiness in areas of responsibility at all times.  Act as a subject matter expert during internal, Global Quality, third party, and health authority audits.  Directly interact with auditors to explain and/or clarify policies, procedures, and examples of equipment and computerized validations.Represent the Quality Facilities and Equipment department as required in management, operation, and organizational meetings.Perform technical review of qualification related documentation.  Provide training/guidance to Quality, Maintenance/Engineering, IT, Manufacturing, and Laboratory personnel on relevant policies and SOPs.Develop short-term and long-term harmonization and remediation strategies with associated timelines and outcomes.Perform other duties as assigned.  QualificationsMake Our Values Your ValuesMylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:Minimum of a Bachelor's degree (or equivalent) and minimum of 2-4 years of experience. Prefer degree in engineering or science based discipline. However, a combination of experience and/or education will be taken into consideration.  Must possess knowledge of and adhere to Company and departmental policies and procedures, as well as government regulations.  Must possess knowledge of current Good Manufacturing Practice (cGMPs), GAMP 5, 21CFR Part 210, Part 211, and Part 11.  Knowledge of EudraLex - Volume 4 and World Health Organization (GMP) guidelines preferred.  A background knowledge in pharmaceutical science or engineering, and equipment/computerized system validation is advantageous.  Knowledge and understanding of pharmaceutical manufacturing equipment, facilities, and laboratory instrumentation preferred.  Must understand and adhere to Company and departmental policies and procedures.Must possess excellent organizational and deductive reasoning skills.  Strong communication and written skills are required.  Working knowledge of Trackwise, Documentum, SAP, and Microsoft Office, including Word, Excel is preferred.  Must demonstrate the ability to multi task by performing multiple projects and tasks simultaneously.  Familiarity with Manufacturing, Regulatory Affairs, Quality Assurance, and Quality Control environments is advantageous.  Must be able to work and interact well with other employees at all levels.  Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.  Ability to work with managers or directors and communicate ambiguous concepts.  Ability to present to groups across the organization.Proficiency in speaking, comprehending, reading and writing English is required.Why Mylan?If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care. Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.

24 days 11 hours ago

Mylan Inc