Lilly Engineer-Validation-FDE in Branchburg, New Jersey
As a Validation Engineer, you will use effective time management skills to run projects to deliver on time and consistent results, and perform validation activities alongside the appropriate functional groups. You will prioritize validation activities, communicate and document status to management and appropriate departments, as well as provide technical evaluations of validation issues supporting discrepancy investigations and develop corrective action plans, as required.
In this role, you will also evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes. You will develop and execute Installation Qualification (IQ)/Installation Verification (IV), Operational Qualification (OQ)/Operational Verification (OV), Performance Qualification (PQ) protocols for biopharmaceutical manufacturing equipment while ensuring validation activities meet internal and external compliance requirements.
Have knowledge of Good Manufacturing Practices (GMPs).
Have understanding of traditional Installation Qualification (IQ) documentation, including P&IDs, MOC, surface finish, weld logs and maps, passivation, etc.
Have some understanding of FDA regulations and guidelines.
Ability to work with others in a dynamic environment.
Have strong communication skills, both oral and written to effectively communicate technical information in a clear and concise manner within a GMP environment.
Strong analytical, problem solving, and excellent interpersonal skills.
Proficient in MS Office (Word, Excel, Project, Powerpoint, Outlook, etc.).
Understanding of chromatography and TFF Skids is a plus.
At Lilly, we are constantly striving to be leaders in diversity and inclusion, clinical research, corporate responsibility and employee benefits. For more than 140 years, we have received recognition from several distinguished organizations for our efforts. Here are some of our 2019 honors:
Catalyst Award, for our innovative Employee Journeys and People Strategy
Corporate Knights, Global 100 Most Sustainable Corporations in the World
Ethisphere, World's Most Ethical Companies
Forbes, America's Best Employers for Diversity
This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years . This position is employed directly by Eli Lilly and includes a competitive benefit package. Please note that Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Engineer-Validation Technical Services FDE
Bachelor’s degree in Engineering, Computer Science, Science, or related discipline.
0-2 years of pharmaceutical/biopharmaceutical validation experience
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. We strive to make life better.
Do you value integrity, excellence and respect for people? Are you seeking a career that makes a difference in the world? Are you looking for a challenging opportunity that gives you the chance to develop strong validation skills? Do you have computer system validation (CSV) skills or are interested in learning? If so, we have a role for you in our Validation Technical Services organization.
The Validation Technical Services (VTS) organization goal is to maintain drug manufacturing systems within a state of compliance, as defined within 21CFR210/211, FDA current Good manufacturing practices. This is accomplished through inspection, field testing, and documentation to back it up.
State / Province: