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Senior Software Validation Quality Engineer
A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Responsible for the guidance and direction of validation projects covering all the Life Science digital equipment, control systems, applications, computerized systems, software / OT (operational Technology-industrial software, cloud-based solutions). You will provide expert guidance on all aspects of computerized systems validation and will directly assist regulatory inspections and audits. The role will provide validation and quality assurance support for computerized systems, digital equipment, process controls systems, software systems, and IT infrastructure that have been newly developed, installed, upgraded, replaced and / or modified for the use in cGMP area. Performing 21 CFR Part 11, Annex 11 and all levels of risk assessments, writing white papers, validation protocols / reports and managing operation controls (change control, periodic review) for multiple equipment/ software applications. Responsible for interfacing and driving Design Assurance principles within New Product Introduction (NPI) teams for design, development and product transfer to manufacturing at MilliporeSigma Danvers, MA site.
• Computerized systems / digital products/ Control Systems/ Software / OT (Operational Technology - industrial software) / Cloud based solutions, IT Validation (IQ,OQ,PQ, Test Scripts, Protocols, Infrastructure qualification protocols, back-up restoration testing, audit trail testing) / quality assurance, Validation Master Plan meeting GAMP, QMS (Quality Management Systems), P/D-DP (Product/Digital Development Process) and regulatory requirements based on the systems need/scope of target market and internal/external use in GMP area.
• Lead in the planning, implementation, integration, testing and management of computerized systems used in collecting, analyzing and/or reporting data.
• Provide guidance and direction for validation and implementation of Electronic Batch Records
• Perform Functional risk assessments, Data Integrity Assessments, FMEA to ensure the requirements, controls are collected prior to development and ensure tested system met those requirements. Including ability to review URS, Functional Spec, Design Spec, Test Scripts, User Manual for computerized systems, digital products, software applications (for both COTS and new products/solutions for target sectors)
• Lead by addressing lessons learned and reviewing complaint data in support of development, modification and improvement of design processes and quality management system
• Help create validation tools to standardize approach by topic and reduce non-value-added activities
• Lead process validation by generating Validation Master Plan (VMP), IQ, OQ and PQ protocols and reports.
• Support supplier assessments
• Perform and facilitate raw material change, new equipment risk assessments and validation.
Who you are:
- 5+ years progressive, seasoned Computer System Validation engineering, design assurance engineering within the biopharma, biotech or medical device industries.
- Minimum B.S. degree in Computer Science, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Chemical Engineering, Biochemistry or equivalent
- Software Quality Engineer Certification (CSQE)
- In depth knowledge of and experience with Computer System Validation and SDLC process
- Full understanding of product, equipment and process validation
- Demonstrated capability of applying risk management concepts and tools.
- Hands-on experience in the application of quality system standards
- Experienced at working in cross-functional teams
- Strong written and verbal communication skills (internal/external)
- Strong teamwork and collaboration skills
- Knowledgeable in 21 CFR Part 11, GCP and GLP regulations.
- Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes
- Experienced with Quality & GxP IT compliance requirements
- ASQ Quality Engineer Certification (CQE)
- Six Sigma Certification
- Quality by Design
- Applied/industrial statistics experience
- Detailed Knowledge of GMP, ISO and FDA design and development quality requirements
- Knowledge of aseptic processing
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. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
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
If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.