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Senior Compliance 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.
The Senior Compliance Engineer at MilliporeSigma in Madison, WI is recognized as a strong technical contributor within the Engineering Team with the following main responsibilities:
- Manage investigations related to Engineering systems (QARs). This includes performing the data gathering for the investigations, write the reports, and coordinate meetings with all the affected parties.
- Track and follow-up on timely completion of CAPAs (Corrective and Preventive Actions) that result from investigations, audits, PQS compliance Assessments.
- Track and follow-up on timely revisions of Engineering SOPs with SOP owners.
- Generate / Review CRs (Change Requests) related to Engineering systems and projects.
- Act as the Engineering main contact for all regulatory and internal audits and inspections. This includes reviewing all information provided to auditors.
- Perform gap analysis on engineering systems regarding Quality Standards.
- Review C&Q documentation on Engineering systems and projects.
- Perform M1 analysis on engineering system failures and identify root causes and corrective actions.
- Provide training to Engineering colleagues on Compliance SOPs.
- Provide technical support to Engineering colleagues on Compliance issues.
- Leads assigned projects by developing schedules, resource loading, and other project deliverables as required. Based on engineering specifications, support validation projects of more technically complex nature on equipment or a process that includes authoring protocols, executing validation protocols, and writing reports of validation results.
- Bachelor of Science degree in an Engineering discipline in Chemical, Industrial, Electrical or Mechanical Engineering
- 4+ years industrial plant engineering experience in a cGMP pharmaceutical manufacturing setting
- Previous experience in managing Change Controls, CAPA’s, SOP’s, M1, C&Q, regulatory agencies audits & Pest Control Programs
- Experience with clean rooms ISO Class 8 preferable
- Strong knowledge of cGMP, FDA, and other countries regulatory agencies such as, EMA, ANVISA and other regulatory standards and requirements for clean utility processes
- Interpersonal and team building skills
- Engineering background with knowledge of clean utilities, and general pharmaceutical plant infrastructure
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 a 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.