Senior CSV Engineer - 100% Remote

Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold.  Help us do it.

External 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.)  Thank you.

Description Overview

The Sr Computer System Validation Engineer provides Quality oversight of Global IT projects.  They will partner with project stakeholders to effectively and efficiently implement and validate new systems, system upgrades, or system modifications.

 

Please note: This position can work 100% remote or near a Perrigo location with a hybrid schedule if desired. 

Scope of the Role

• Works with IT and user groups to evaluate change control requests by assessing regulatory risk and determining corresponding validation requirements.  
• Author, review, or approve lifecycle documents (URS, Validation Plan, Specifications, Risk Assessment, Qualifications IQ/OQ/PQ, data integrity evaluations, trace matrix, SOPs, and Validation Summary Reports).
• Reviews global policies, SOPs, and work instructions supporting the quality management system and computerized/IT applications and infrastructure
• Maintains the site Validation Master Plan and systems catalog.
• Perform CSV periodic review for IT systems.
   

Experience Required

• High level of analytical skills with proven problem-solving ability, and good interpersonal skills. 
• Demonstrated ability to organize multiple tasks and to change priorities to meet project deadlines.
• Ability to work with cross-functional group at all levels of organization.
• Working knowledge of computer validation requirements in government regulations including, 21 CFR Part 11, Annex 11, data integrity, and GAMP. 
• Ability to write technical documents relating to applications and computer systems of medium to high complexity.
• Demonstrated thorough understanding of validation processes and interpretation and application of FDA, EU, and cGMP requirements.
• Bachelor’s degree in Computer Science, Engineering, Programming, or a related field.
• A minimum of 7 years of pharmaceutical industry experience preferred.

External 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.)  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.  Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV