Senior Validation Engineer
MilliporeSigma

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.

Your Role:

The Senior Validation Engineer is a subject matter expert in either equipment validation, computer system validation or both. The Senior Validation Engineer manages and executes validation projects in their area(s) of expertise at the Rockville, MD site.

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.

• Defines, plans, and manages validation projects while meeting applicable regulatory requirements
• Generates, executes and manages validation deliverables under minimal supervision
• 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
• 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
• Works on problems of complex scope in which analysis of the situation or data requires a review of identifiable factors
• Exercises judgment within defined procedures and practices to determine appropriate action
• Interacts with outside customers and functional peers' groups (System Owners, IT, QA) at various management levels to gain cooperation, foster collaboration and influence project outcomes
• Provides mentoring to other personnel
• Conducts presentations of technical information for specific projects or general validation procedures
• Determines validation approach and relevant SOPs on new assignments
• Subject matter expertise of equipment and/or computer systems used in a GxP environment
• Subject matter expertise of regulatory requirements for computer systems and/or equipment in use
• May perform other related duties as required and/or assigned

Physical Attributes:

• 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 excess of 100 decibels
• 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

Who You Are:

Minimum Qualifications:

• Bachelor's degree in a scientific (i.e. Biology, Chemistry, etc.) or engineering (i.e. Computer Engineering, Information Technology Engineering, etc.)
• 5+ years validation experience

Preferred Qualifications:

• Prior experience with development and execution of validation documents related to Analytical or Computerized systems
• Knowledge of Data Integrity requirements and experience verifying DI controls
• Prior experience in medical, biotechnology or similar field
• Knowledge of manufacturing concepts and GMP
• Demonstrates technical proficiency, scientific creativity, and collaboration with others and independent thought

RSRMS

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.

Job Requisition ID: 223136

Location: Rockville

Career Level: D - Professional (4-9 years)

Working time model: full-time

This job has expired.