A career with MilliporeSigma is an ongoing journey of discovery: our 50,000 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.
The cGMP Facilities Engineer, located in St. Louis, MO, USA provides operational support of the GMP Manufacturing clean utilities associated with bulk drug substance manufacturing.
Your role: The GMP Facilities Engineer is recognized as a strong technical contributor within the Operations Team supporting the clean utilities required for cGMP API manufacturing. This position will support the Sr. Production Engineer for all clean utilities at the site, including purified water, WFI, Clean Steam, Clean Air, CIP/SIP systems, and process gases, and other supporting equipment and infrastructure. The GMP Facilities Engineer will be responsible for coordinating activities 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 clean utilities.Â
Who you are: Â To succeed in this role, you should have âhands onâ experience in a GMP manufacturing environment. Weâre looking for a candidate with strong technical engineering skills, demonstrated ability to work within a cross-functional team, and excellent interpersonal and team building skills.
- 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. Engineering background with knowledge of WFI, clean utilities, and general pharmaceutical plant infrastructure. Experience with FDA, EMA, and other regulatory standards and requirements for clean utility processes desired.
- Professional Skills, Qualifications, Experience:
- Support all activities associated with siteâs clean 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 Operationsâ schedule
- Maintenance of quality systems and cGMP compliance
- Ability to understand regulatory requirements such as ICH Q7, 21CFR Part 210 and 211, 21CFR Part 600, and EMA guidelines as they relate to clean utilities and pharmaceutical manufacturing.
- Assist with the execution of manufacturing processes by interfacing with the Process Engineer
- Provide training on clean utilities
- Assists in factory and site acceptance testing for new equipment
- 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
- Generate and/or review user requirement specifications for clean utilities and processing equipment
- Identification, recommendation and implementation of replacement-in-kind, new or improved equipment and/or systems in support of existing clean utilities as well as new or existing manufacturing processes
- Ability 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: None to Minimal travel
- 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 operation.
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 come2emd.com
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