A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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 Head of Engineering & Maintenance, located in Madison, WI, USA, leads our technical staff that supports GMP operations at the Madison and Verona locations. The sites perform contract manufacturing of clinical and commercial APIs, including High Potent compounds. The facilities meet EU and FDA compliance criteria and are subject to frequent regulatory and customer audits. You will be responsible for direction and coordination of technical functions supporting all facilities, including office and operational areas. This individual will hold responsibility for maintenance, repair, change management and preventative maintenance of equipment and facility to ensure that the areas are maintained in accordance with all safety, quality, cGMP and applicable regulatory requirements. In addition, this individual manages capital investment projects and engineering resources to support them.
ESSENTIAL JOB FUNCTIONS
- Direct the maintenance, renovation, repair and daily upkeep of all GMP facility areas and equipment in compliance with regulatory standards that apply to the manufacture of Active Pharmaceutical Ingredients (APIs).
- Communicate daily with operations teams for status of facility and equipment needed for ongoing production.
- Manage and support Preventative Maintenance programs, planned facility shutdowns, and proactive equipment reliability assessments to ensure maximum plant capacity
- Support new equipment installation and start-up
- Identify and maintain inventory of replacement parts for critical equipment.
- Manage a 5-year capital plan & budget and the project engineering activity necessary to support capital investment
- Prepare justification to obtain funding approval for capital projects
- Promote a culture of safety, quality and compliance, and achieve continuous improvement.
- Assure compliance with all safety, quality and regulatory requirements.
- Implement metrics necessary to monitor the effectiveness and continual improvement of the assigned functions.
- Assist in development of departmental budget and manage areas of responsibility within approved budget and contracted scope of work.
- Lead projects to support improvement efforts in the areas of cost savings, quality &/or safety improvements, utility optimization etc.
- Ensure adequate staffing and structure of resources are maintained to support 24/7 operations including contractors as needed.
- Provide for the training and development of employees necessary to support business and quality objectives.
- Attract, hire and retain skilled talent
- Selects and manages vendors and contractors and evaluates performance
- Participate as the primary maintenance/facilities representative for customer and regulatory audits
- Partner with Quality group to report, investigate and resolve deviations
- Partner with Operations to identify and mitigate risks that could adversely impact project outcomes and timely delivery of product to customers
Who You Are:
- Minimum 5 years demonstrated experience in a leadership role for Maintenance/Engineering technical functions in an API manufacturing environment
- Preferred: Bachelor's degree in relevant technical discipline (Chemical Engineering or related engineering/scientific discipline).
- Understanding of manufacturing equipment and systems, as well as typical support utilities such as HVAC, high purity water, and process heating/cooling
- Experience with interpreting government regulations and codes as it applies to facility requirements
- Experience with SAP a plus
- Green belt or other operational excellence certification a plus
- Excellent problem solving and root cause analysis capabilities
- Project management skills - ability to monitor complex projects and direct activities to successful project completion
- Travel Requirements: Minimal travel (1X per year)
- Physical Requirements (PPE, lifting): Must be able to lift and/or move up to 50 pounds and to wear PPE associated with construction or maintenance activities (Hard hat, safety glasses, gloves, hearing protection, etc.)
- Ability to work near moving mechanical parts, outdoor weather conditions, sources of electrical shock, vibrations, fumes, airborne particles and hazardous chemicals while wearing appropriate PPE
- Work schedule: Day shift, 8am - 5pm M-F. Required to be available for weekend and holiday on- call and after hour's duty as needed.
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.