cGMP Engineering & Maintenance Compliance Specialist

Posted 25 Feb 2019

St. Louis, Missouri - United States

Req Id 187818


A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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.

Your Role:

The Engineering and Maintenance Compliance Specialist's primary role is to provide support to the cGMP operations. This position will be responsible for assisting Engineering, Manufacturing, Technical Operations, and QA with quality support as it relates to change control, equipment non-conformances, process deviations, routine equipment system maintenance and Building Management System support. Additional responsibilities may include on the floor oversight during manufacturing, incident investigations and resolution, monitoring of the building management system.

Essential Job Functions:

  • Coordinate documentation and tasks associated with equipment and facilities:
    • Change management
    • Addition of new equipment
    • Preventative maintenance and Calibration
    • Non-Conformances and CAPAs
  • Work with Engineering, Technical Operations, Maintenance, Manufacturing, Validation, and Quality Assurance to ensure that change controls, deviations, CAPAs are reviewed, approved and implemented as appropriate
  • Assist with equipment and facility investigations, trouble-shooting, and root cause analysis
  • Assist with the management of preventative maintenance tasks, change control, and equipment/facility shut-down activities
  • Assist with equipment and facility risk assessments
  • Ensure planned and unplanned work is prioritized and managed closely to minimize disruptions to Operations' schedule
  • Maintenance of quality systems and cGMP compliance
    • Ability to understand regulatory requirements such as ICH Q7
    • Supports equipment commissioning, qualification and validation activities related to GMP manufacturing
    • Write, review and/or assist in the development of Manufacturing, Facility or Equipment Operating Procedures
    • Assist with customer and regulatory audits
    • Assist in the generation of Engineering CAPA, deviation, and change control trend reports
  • Drive continuous improvement to support customer and regulatory expectations
  • This position will reside in an office setting. Global travel may be required for training and auditing purposes.

Who You Are:

Minimum Requirements:

  • Bachelor's degree in Engineering, Chemistry, Biochemistry, or other Life Science field
  • 1+ years of work experience supporting a GMP Manufacturing group.
  • 1+ years of experience with Trackwise or SAP, specifically the Quality Management and Engineering Change Control Modules

Preferred Qualifications:

  • 2-3 years of experience in equipment systems administration preferred
  • Strong computer, document management and attention to detail
  • Ability to work within a cross-functional team
  • Excellent oral and written communication skills
  • Effective, disciplined, and demonstrated documentation skills

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at

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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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