- Assess and define assigned validation projects. Liaise between engineering and quality assurance throughout validation lifecycle of packaging equipment and data historian network.
- Develop validation strategy based on URS and pFMEA
- Writing, reviewing, and implementing project validation protocols for standard & customized systems.
- Raise discrepancies and closeout test documentation.
- Prepare validation summary reports for completed protocols
- Conduct deviation investigations, such as validation failures, complaints, and hold investigations. To Identify & implement the appropriate corrective actions.
- Applying structured problem-solving tools, work with Operations to resolve technical issues and rationalize impact to validated state.
- Author operational guidance documents (SOP/WI/JA/FORM) and conduct trainings
- Travel to support FAT executions
- Partner with quality assurance team to participate in internal and external audits to defend equipment validation packages including calibration and maintenance
- Minimum of 3 years of validation experience in a regulated industry or equivalent validation experience that included the development and execution of FAT, SAT, and IQ/OQ protocols required.
- Experience with DeltaV or similar automation system preferred.
- Experience working with Trackwise, Maximo, and other electronic document management systems preferred.
- Experience applying Data Integrity Principles (ALCOA) as part of standard work preferred.
- Experience with computer systems validation, cleaning validation, and environmental monitoring preferred.
- Demonstrated understanding of cGMP, GDP, and regulatory requirements for automated systems, CPPs, and CQAs, pFMEAs
- Knowledge, Skills, Abilities
- Great teammate who enjoys working on a dynamic team and making an impact
- Driven to successfully evaluate risks, opportunities, and roadblocks to make the best decisions to achieve your goals and the team's goals.
- Diligent collaborator whose comfortable influencing, informing, and instructing peers and members of the leadership team throughout all levels of the organization.
- Hands-on engineer with comfortability being present in and working in and around manufacturing areas and equipment.
- This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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Engineer III, Validation - Indianapolis, United States - Thermo Fisher Scientific
Description
Job DescriptionAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer
Location/Division Specific Information
Thermo Fisher Scientific run's the World's largest clinical packaging operation. Our Clinical Trials facilities are strategically placed around the world to accommodate local and regional sourcing needs. Join us to help serve millions of our global clinical trials patients
How will you make an impact?
The Process Validation Engineer will mentor and support in the diagnoses and resolution of software, instrument, and process problems to maintain system readiness of both packaging equipment and data historian network. You will ensure site compliance and all vital activities are performed on time to keep all validated systems in a validated state. In this role, you will also create and implement the site's validation strategy.
What you will do
Education:
Bachelor of Science Degree in Engineering or another scientific subject area from an accredited College or University
Experience:
Apply today
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
