Who We Are: MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany – a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
Your Role: The Senior Validation Engineer is a subject matter expert in either analytical equipment validation, computer system validation or both. The Senior Validation Engineer manages and executes validation projects. Responsible for the successful execution of validation projects meeting regulatory requirements according to the prioritized project timeline. The projects may be executed by the Senior Validation Engineer and/or managed by the Senior Validation Engineer employing other validation engineers, contractors or a combination of resources. This position does not have direct reports.
Who you are: Defines, plans, and manages validation projects and deliverables under minimal supervision while meeting applicable regulatory requirements and ensures the timely delivery of validation deliverables to allow for validation peer review and QA approval to be completed within the project schedule. Acts as a team member in the selection, design, and implementation of new or updated IT infrastructure, application programs, databases, laboratory equipment automation systems, and/or other hardware to be validated or used in validation projects. Initiates, reviews and updates detailed system documentation, procedures, policies and standards in accordance with regulatory guidelines and works with Validation management to develop life cycle documentation and validation standards. Contributes to long-term planning for the Systems Validation business model including team goals, metrics and budget.
- B.S. in Science or Engineering
- Minimum of 5 years validation experience.
- Prior experience with development and execution of validation documents related to Analytical or Computerized systems in medical, biotechnology or similar field.
- Knowledge of manufacturing concepts and GMP.
- Demonstrates technical proficiency, judgement and action, scientific creativity, and collaboration with others and independent thought.
- Interacts with internal customers and functional peers groups (System Owners, IT, QA) at various management levels to gain cooperation, foster collaboration and influence project outcomes.
- Conducts presentations of technical information for specific projects or general validation procedures.
- Will determine validation approach and relevant SOPs on new assignments.
Additional Local Needs:
- While performing this job, the employee may be exposed to moving mechanical equipment, harsh and/or toxic chemicals and biologicals, low levels of radiation, extreme cold (-70C) and noise in access of 100 decibels.
- Must be able to walk, stand, reach above the shoulders, use a cellular phone, use feet to operate equipment, stoop, kneel, crouch or crawl, talk, hear, use hands to operate tools and equipment.
- Some work related travel may be required (≤10%).
What we offer: Your possibilities to develop in our growing company are just as manifold as our product portfolio. We offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.
MilliporeSigma 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.