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Facilites Engineer, cGMP

 

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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.

 

Your role:

The GMP Facilities Engineer is recognized as a strong technical contributor within the Operations Team supporting the facilities & utilities required for cGMP API manufacturing. This position will support the sites in Madison and Verona, WI for facility systems and utilities, including purified water, air handling systems, heat/cooling systems, electrical, and other supporting equipment and infrastructure. The GMP Facilities Engineer oversees tasks for coordinating activities with contractors and with other departments including Manufacturing, Maintenance, Engineering, Quality Assurance, Validation, Quality Control, Project Management, and Process Development.  In addition, the GMP Facilities Engineer may also interface with customer personnel, auditors, and regulatory authorities, as needed, to communicate system design, qualification, and status of facility systems and utilities.

 

  • Support activities associated with site’s infrastructure and utilities, including but not limited to, operation, qualification, preventative maintenance, change control, shut-down activities, risk assessments, leading investigations, trouble-shooting, root cause analysis, and CAPA implementation
  • Ensure planned and unplanned work is prioritized and managed closely to minimize equipment downtime and disruptions to Operations’ schedule
  • Ensure all activities are performed in accordance with safety, quality, cGMP, and applicable regulatory requirements
  • Ability to understand regulatory requirements such as ICH Q7, 21CFR Part 210 and 211, 21CFR Part 600, and EMA guidelines as they relate to utilities and pharmaceutical manufacturing facilities
  • Identify, qualify and oversee contractors needed to perform on-site work, including adherence to safety and quality site standards and procedures.
  • Assist in factory and site acceptance testing for new equipment
  • Support 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
  • Generate and/or review user requirement specifications for utilities, facility, and processing equipment
  • Identification, recommendation, and implementation of replacement-in-kind, new or improved equipment and/or systems in support of existing utilities as well as new or existing manufacturing processes
  • Aptitude to read and interpret P&IDs, equipment manuals, and electrical/mechanical drawings
  • Work with other disciplines to ensure the necessary details related to the systems are fully coordinated
  • Research equipment providers and make recommendations and selections based on project requirements and business needs
  • Drive continuous improvement to support customer and regulatory expectations
  • Travel Requirements: Minimal travel may be required for factory acceptance testing of equipment and/or best practice sharing between sites.

  • Physical Requirements: This position requires occasional lifting of no more than 35 lbs and pushing heavy vessels/ equipment.

  • Work Schedule: Must be able to work independently on a variety of shifts as needed to support utility operations.

 

Who you are:

Basic Qualifications:

  • Education: B.S. in an Engineering discipline (preferably Chemical or Mechanical Engineering), or equivalent degree
  • Minimum of 3+ years relevant industrial plant engineering experience in a cGMP pharmaceutical manufacturing setting.
  • 3+ years of Engineering background with knowledge of utilities, and general pharmaceutical plant infrastructure.
  • 1+ years of experience of modeling facility systems Aspen Hysys or UniSim or 1+years of general programming experience
  • 3+ years of experience with FDA, EMA, and other regulatory standards and requirements for facility and utility processes 

 

Preferred Qualifications:

  • To succeed in this role, you should have “hands-on” experience in a GMP manufacturing environment.
  • Strong technical engineering skills, demonstrated ability to work within a cross-functional team, and excellent interpersonal and team-building skills.

 

 

 

 

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil 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 https://jobs.vibrantm.com


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.

Job Requisition ID:  217118
Location:  Madison
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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