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Pilot Process Engineer
A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 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.
US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of fully vaccinated assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.
We are seeking an experienced Manufacturing/Process Engineer with a focus on mechanical and automation equipment development, implementation, and validation to join our Pilot Production Team in Jaffrey, NH. The Pilot Team is focused on the development and production of single-use biopharmaceutical devices and assemblies. This position will primarily be working with a team of engineers and technicians by leading projects that support the manufacturing floor. It requires regular interaction with other engineers, technicians, quality, R&D and production operators. Proactively evaluate all activities within a work cell and apply knowledge of product design, fabrication, assembly, tooling, and materials to resolve problems quickly. Assist in providing innovative automated solutions to existing manual processes through collaboration with equipment suppliers and internal colleagues.
The idea candidate will:
- Utilize data to identify gaps in process robustness and develop improvement plans
- Assess the projected cost of the proposed improvements and manage the budget for these efforts
- Manage overall improvement plan. This includes driving team to meet objectives, schedule, and budget
- Communicate status, risks, and progress of qualification efforts to management and key stakeholders
- Develop and write equipment documentation (i.e. VMP, URS, FAT, Equipment IQ/OQ/PQ, DOE, and SOPs) for appropriate equipment and systems within the guidelines of cGMP, internal policies, and procedures
- Provide guidance for the safe installation, maintenance and troubleshooting of automation machinery and equipment
- Train operators and Maintenance Technicians on new equipment and process
- Develop, evaluate, improve, and document mechanical assemblies used in the manufacturing processes
- Design fixtures, tooling, and conceptual mechanical layouts
- Provide engineering support in operations to trouble shoot and resolve technical mechanical and electrical issues
- Support company policies and procedures, goals, and objectives, all regulatory and GMP requirements
- Lead LEAN initiatives within the Pilot work center
Who You Are:
- Bachelor’s Degree in Engineering (e.g., Manufacturing, Industrial, Mechanical, Design)
- Strong communication and interpersonal skills, ability to collaborate across disciplines
- Capable of working on multiple tasks, meet established deadlines and demonstrate strong attention to detail
- Ability to self-direct toward individual milestones as part of team projects with a strong sense of responsibility, urgency, and high energy with a positive behavior
- 2+ years of manufacturing experience.
- Prior experience in medical, biotechnology or Bio-pharmaceutical manufacturing environment is highly preferred
- Knowledge of Quality Systems (Exception, Investigation, CAPA, Risk & Change Management), with experience in establishing, improving, managing & assessing Quality Systems
- Experience in process development and improvement including leading risk assessments and FMEA's leading and managing teams
- Ability to work in a matrixed team environment with demonstrated capability to influence and manage w/o authority
- LSS Green Belt, Lean manufacturing experience/knowledge
- Aptitude to grasp modern technology quickly
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
If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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.