Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role:

The Senior Computer System Validation Specialist is responsible for driving compliance and validation projects, and establishing technical strategy to enhance efficiency, regulatory compliance, and operational excellence, including Data Integrity for GMP manufacturing and laboratory systems. The successful candidate will be part of a collaborative environment that fosters continuous learning, career growth, and interface with key stakeholders to validate both local and enterprise systems, maintain validation rigor to ensure sustained quality and compliance.

 

Major Position Activities & Responsibilities:

Computer System Validation / Computer System Data Integrity for all systems that contain processors and or generate data including lab, manufacturing, and IT based systems utilized in the support of cGMP activities, including developing and executing qualification protocols. As the cGMP computer system validation / computer system data integrity expert, develop and maintain company policy and procedures related to computer system validation and computer system data integrity Develop training curricula and provide training for and enforcement of data integrity policy and procedures site wide. Provide ongoing coaching to ensure effected personnel understand CSV process and government regulatory guidelines in preparation for internal/external audits Advises from a cGMP perspective, the functional areas on strategies for the life cycle management of data residing within computer systems (i.e. collection, storage, maintenance, backup, recovery, archival, retirement)Perform (lead) cGMP gap assessments with the functional areas for current computer system validations against cGMP expectation and current industry expectations. From a cGMP validation perspective, advises applicable functional areas on computer system validation and remediation approaches for new and existing systems. This includes aid/develop 21 CFR part 11 assessments for new and upgraded systems and software.Develop and execute system validation deliverables based on software/hardware configuration for enterprise systems. Update or create application system User Requirements, Functional, and Design Specifications Review and perform approval of validation change controls, protocols and completed validation packages finalized by other functional areas.Continually improve CSV and Computer Systems Data Integrity by investigating, developing and implementing permanent corrective and preventive actions for process/system failures. Coordinate investigations to determine root causes and actively participate to develop and propose changes to prevent reoccurrence of issues Maintain qualification of Quality Assurance auditor and assist the Supplier Quality department in the performance of audits of computer systems vendors and service providers when requested.

Who You Are

Minimum Qualifications:

Position requires a bachelor’s degree in computer science or information technology or related field with a Master’s degree preferred.Ten (10) years or more of CSV experience in pharmaceutical or life science or medical device industry experience.Strong Knowledge of EU, FDA and cGMP regulations related to the Pharmaceutical and Life Science Industry. Auditing experience within regulated industry, auditing suppliers/contractors, certified quality auditor is a plus. Excellent interpersonal effectiveness, conflict management skills, experience in technical writing, communicating across organizational levels are must.  

Preferred Qualifications:

Master’s degree preferred.Proven skills of coaching/mentoring staff in a cGMP/GLP environmentKnowledge of SAP, Nugensis, Novatek, Valgenesis is highly desirable. 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html