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 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.
As a Project Engineer II, you will be an integral part of a dynamic Capex team and will actively participate on all project aspects, regarding new automated manufacturing equipment. In this role you will be a core member of a results driven project team. You will interact effectively with people in all areas of the company including Process, Operations, Quality and EHS, as well with external vendors. The successful candidate will be an enthusiastic team player, willing to take on new challenges with high energy and strong engineering skills.
- Responsible for the URS, design, functionality, test methods and operational quality of new equipment.
- Author validation protocols, lead execution, and author reports, including resolution of deviations to the protocol.
- Ensures that new equipment features meet product specifications and comply with process validation requirements.
- Develop, change and author project documentation that includes, SOP’s, Process Specifications, Training Forms, Calibration requests, Change Control deviations, Batch records and PM’s.
- Coordinate product testing / DOE’s with the appropriate disciplines and provide test results, analyses, and recommendations to the project team.
- Lead and contribute to technical risk assessments (Design, Process, Safety and Application FMEA’s).
- Reviews capital equipment fabrication activities to ensure manufacturing, construction, installation, and operational testing conform to functional specifications, regulatory safety standards, and user requirements.
- Investigates and develops new processes required to improve manufacturing operations and processes.
- Develops cost estimates, obtains quotes, and generates capital requests to support new processes and capital equipment purchase.
- Ensures that product quality features meet product specifications and comply with process validation requirements.
- Facilitates training for individuals involved with the operation and maintenance of processes and equipment introduced to the manufacturing department.
Who you are:
- Bachelor of Science Degree in Electrical, Mechanical or Chemical Engineering with relevant professional experience (2+ years) in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting capital equipment projects. Non-graduate jobholders require a substantial amount of professional experience and additional qualifications that also provides exposure to fundamental theories, principles and concepts.
- Knowledge or willingness to learn AutoCAD, and 3D modeling software (SolidWorks, Inventor, and/ or ProE). PLC Code, Instrumentation, SPC,
- Works comfortably in production environments and has hands-on approach to problem solving.
- Experience with automated equipment is a plus.
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.