Description Overview
In this role you will be responsible for the preparation and execution of validation protocols according to the Validation master plans and schedules in Process Validation (including Performance Qualification, product hold time and transport studies), Equipment Qualification, Cleaning Validation, Computer Systems Validation, Spreadsheet Validation and execution and reporting of temperature profile mapping for Quality Critical equipment
You will also conduct periodic lifecycle reviews for each of the validation disciplines, and support Improvement projects with technical input and participating in problem solving teams (e.g CAPA, Quality Event, Kaizen).
Scope of the Role
Validation
• Generate and assist in the completion of qualification and validation protocols to enable the compliant and efficient introduction of new or changed products, processes, equipment, computer systems, spreadsheets and cleaning procedures.
• Report results and findings following execution of protocols.
• Conduct lifecycle reviews for products/processes, equipment, cleaning processes, computer systems, spreadsheets and temperature profiles for quality critical temperature-controlled equipment
Process Improvement
• Work in collaboration with Quality Engineering and Operational Excellence to provide validation and qualification expertise in improvement initiatives. Provide data via validations to support product control plans and risk assessment processes.
• Take an active role in CAPA action teams, QE investigation teams and Kaizen events where required.
Risk Assessment
• Identify via risk assessment, validation and qualification requirements for both new and changes to existing products, processes, equipment, cleaning procedures, computer systems and spreadsheets.
Other
• Undertake such other reasonable duties as may be required from time to time in order to support the Perrigo business.
Experience Required
1. Minimum of 2 years’ experience of validation or process engineering roles in the pharmaceutical or other regulated industry
2. Knowledge of GMP and its application in validation and change management and improvement processes, ability to learn new regulations
3. Ideally experience of working in an environment employing some elements of lean management, but not essential
Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about at Perrigo. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) All application materials, including resumes and CVs, must be submitted in English. Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo