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.
Validation engineers are recognized as a strong quality presence and technical resource. This position is responsible for developing, reviewing, and managing the execution of validation activities, and ensuring that the qualifications are consistent with user’s/manufacturer’s requirements and quality standards.
In the role of Validation Engineer, you will also be interacting cross-functionally with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance.
- Create and execute protocols for equipment, cleaning, and facility. (including but not limited to FAT/SAT/IOQ and PQ documents)
- Utilize GDP in a GMP atmosphere while generating protocols and reviewing documents.
- Review and generate closing reports for executed protocols.
- Create validation schedules, coordinate execution efforts with contractors, production operators, production engineers, customers and quality assurance staff members.
- Ability to work through a Management of Change system to determine the impact of proposed changes to the qualification status of equipment, software, or facilities.
- Sound understanding of Quality Risk Management concepts.
- Specific Responsibilities to include:
- Equipment and Facility Validation:
- Develop/Establish an overall plan for qualifying new equipment or new/upgraded facility and establishing the proper controls for the introduction of equipment/facility and/or changes under proper quality standards (e.g. FDA, EU, ISO, ISPE, etc.)
- Identify and establish revalidation requirements.
- Write and execute qualification packages, technical reports, and validation master plans
- Cleaning Validation:
- Develop cleaning validation protocols for equipment and facilities.
- Develop clean/dirty hold times
- Ability to Calculate Maximum Allowable Carryover (MAC) limits
- Execute protocols for cleaning process validation and Clean/Dirty hold time validation
- Hold regularly scheduled cleaning validation meetings with a cross functional team to drive processes to obtaining a validated state
- Work independently and as a part of a team to achieve completion of cleaning validation tasks
- Strong understanding of pharmaceutical cleaning techniques
Who you are:
- B.S. in an Engineering discipline, or Life Science degree.
- Required: 2+ cleaning validation experience in a cGMP manufacturing setting
- Ability to utilize GDP during document creation and review.
- Working knowledge of current regulatory guidelines and standards.
- Ability to apply and incorporate pharmaceutical standards, rules and guidances. (e.g. FDA, EU, ISO, ISPE, etc.)
- Ability to conduct complex math and understand the inputs required for MAC calculations.
- Travel Requirements: minimal travel required for the execution of FAT’s.
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.