18 days old

Senior Compliance Engineer

MilliporeSigma
Madison, Wisconsin
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

Relocation Assistance available and Sign- On Bonus of $10,000 for 1st Shift!

 

Your Role: 

 

The Senior Compliance Engineer, located in Madison, WI manages the Compliance aspects of Engineering, Facilities, & Maintenance for the Madison and Verona locations.  This includes SOPs revisions, CAPAs, QARs, CCs, commitments, quality standards, audits, etc. Responsible for ensuring that current commissioning practices and compliance expectations are integrated into all work performed by the group.  Represent the engineering department as subject matter expert of commissioning requirements for assigned projects. The Senior Compliance Engineer at MilliporeSigma 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, and Gap Assessments,
  • Track and follow-up on timely revisions of Engineering SOPs with SOP owners.
  • Review all CCs (Change Controls) 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 small 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 commissioning protocols, executing validation protocols, and support reports of validation results. 

 

 

Requirements

Who You Are:

 

 

Minimum Qualifications:

  • Bachelor of Science degree in an Engineering discipline
  • 4+ years industrial plant engineering experience in a cGMP pharmaceutical manufacturing setting 

 

Preferred Qualifications:

  • Bachelor of Science degree in Chemical, Industrial, Electrical, or Mechanical Engineering
  • 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
  • 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
  • Strong Technical Engineering skills
  • Ability to work within a cross-functional tea

Categories

Posted: 2022-09-08 Expires: 2022-10-08

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Senior Compliance Engineer

MilliporeSigma
Madison, Wisconsin

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