A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 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.
Validation Personnel 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.
The role of Computerized system Validation Engineer is to provide validation support for computerized systems, Process Controls systems (e.g. Siemens, DeltaV), software, and IT infrastructure that have been newly installed, upgraded, replaced and / or modified in a cGMP Manufacturing Facility. You will also be interacting cross-functionally with Manufacturing, Project Management, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance.
- Computer / Control Systems Validation:
- Develop validation protocols to test computer system and network security, audit trail review, backup and restore functionality.
- Develop validation protocols do document software, firmware and hardware upgrades to validated computerized systems.
- Develop Validation protocols (IQ, OQ, PQ) for established computerized systems/process control systems (e.g. DeltaV, Siemens, etc.)
- Generation of software qualification protocols.
- Ability to review Design Documents for computerized systems.
- Execute protocols for computerized systems, equipment, and process controls.
- Review and generate closing reports for executed protocols.
- Working knowledge of SQL databases.
- Assist with Site Level Data Integrity and 21 CFR Part 11 projects.
- Assist system/equipment owners to generate risk assessments, development of User Requirement specifications, and developed FDS (Functional Design Specifications)
- Assist other validation engineers with the qualification local PLCs on small equipment (e.g. HMIs on reactors and cleaning skids)
- Ability to formulate and analyze software requirements
- Utilize GDP in a GMP atmosphere while generating protocols and reviewing documents.
- 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 software, computerized systems or a process control system.
- Understanding of Quality Risk Management concepts.
Who you are:
- Education: B.S., A.S, or equivalent in a Computer Science, an Engineering discipline (e.g. electrical or computer), Mathematics or Physics.
- General working knowledge of computer system architecture: Client-Server, Networking/ Communication, Virtual & Physical Storage & Application Servers.
- Working knowledge of process control systems (e.g. DeltaV, Siemens, AllenBradly etc.)
- Knowledge in GAMP requirements and interpretation to implement based on the software category in GxP manufacturing, quality control environment.
- 2+ years computer or process controls experience
- Professional Skills, Qualifications and Experience:
- Ability to utilize GDP during document creation and review.
- Ability to apply and incorporate standards, rules and guidances. (e.g. FDA, EU, ISO, ISPE, 21 CFR Part 11, etc.)
- Comfortable in a fast-paced environment with the ability to adjust to changing priorities.
- Flexible and accountable.
- Detaile oriented work standards.
- Travel Requirements: rare 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 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.