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.
The Manufacturing Engineering Manager is responsible for manufacturing run readiness (including related equipment, verification of technical training) and manufacturing risk profiles. Major focus is on Upstream, Downstream, and/or Manufacturing Science equipment and operations. The Manufacturing Engineering manager will own equipment validation strategies as customer and/or other products enter the facility for the first time. This role will also support interdisciplinary project teams by means of technical competence. The Manufacturing Engineering Manager will assume responsibility as engineering technical lead on production/operational equipment related projects.
The Manufacturing Engineer Manager will demonstrate a high level of competency and know how related to functional aspects of technical cGMP biopharmaceutical manufacturing systems. The Manager will guide projects and team leaders to insure production processes are efficient, accurate, compliant and manufacturing readiness standards are identified and met. This role will conduct themselves with honor and integrity as demanded by the nature of cGMP clinical and commercial production of vaccines and biologic therapeutics intended for human use. In addition, this position is responsible for collaborating with the manufacturing staff working in the facility to meet corporate production goals, as well as influencing related, cross-functional groups to meet these objectives. This position plays a significant role in unifying the manufacturing process transition from PD to steady state commercial operations.
ESSENTIAL JOB FUNCTIONS
Develop and optimize continuous production and manufacturing processes to achieve the output, quality, and cost goals of the organization. Collect production data and apply standard scientific statistical methods to analyze, document, and diagram production flows. Identify Manufacturing bottlenecks and devise solutions to resolve them. Determine appropriate attendees for meetings to discuss and implements solutions. Recommend changes or upgrades to equipment, work methods, or other aspects of the Manufacturing to improve efficiency and utilization of resources (including labor, energy and raw materials). Promote and ensure the culture of quality while providing troubleshooting and in-suite guidance to achieve timely production completion goals. Motivate peers and staff, to foster a culture of continuous improvement and operation excellence. Supervision: Works on Projects/matters of moderate complexity in a support role.
Who You Are:
- Bachelor of Science degree in a science or engineering related field.
- 3+ years of directly related experience within Manufacturing or Engineering in a support function.
- 3 + years of leadership experience in a GMP environment
- 3 + years’ experience in biopharmaceutical equipment validation
- 5 + years’ experience with MS Office programs Word, Excel and PowerPoint
- 3+ years Supervisor or Manager experience
- Lean Six Sigma methodologies
- Working knowledge of technical equipment such as bioreactors, chromatography, bioanalyzers, isolators
- 5 + years working with aseptic manufacturing processes
- 5+ years of leadership experience in a GMP environment highly preferred
- 5 + years’ experience in biopharmaceutical equipment validation
- Statistical software experience preferred
ADDITIONAL LOCAL NEEDS
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
The employee must be able to work off-shifts, weekends, and additional hours as required.
The employee must have the ability to perform moderately physical activity.
The employee must have the ability to perform very complex tasks with attention to detail.
The employee must be self-motivated, work well in a group, and communicate well with all levels of the operations team.
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 come2emd.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 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.