Lilly Engineer-Validation Technical Services in Branchburg, New Jersey
Title Engineer-Validation Technical Services
State / Province New Jersey
Company Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Responsibilities This position is an entry level validation engineer that requires some knowledge of cGMPs, excellent technical writing, and problem solving skills. Responsibilities will include but not limited to: Development and execution of qualification and validation protocols, ensuring qualification and validation activities meet internal and external compliance requirements, effectively manage projects to deliver on time and consistent results, and coordinating validation activities with the appropriate functional groups. Previous experience performing CIP and SIP is recommended
Develop and execute Installation (IQ), Operational (OQ), and Performance Qualification (PQ) protocols for biopharmaceutical manufacturing equipment
Operate and maintain data acquisition systems and validation testing instruments including the Kaye Validator and wireless data loggers
Use effective project management skills to ensure on-time project delivery
Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes
Evaluate and perform CIP and SIP requalification activities
Bachelor’s degree in Engineering, Science, or related discipline.
Minimum 2 years 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
Understanding of FDA and EU regulations and guidelines and knowledgable of current industry trends
Ability to work with others in a fast-paced environment
Must have strong communication skills, both oral and written to effectively communicate technical information in a clear and conse manner within a GMP environment
Strong analytical, problem solving, and excellent interpersonal skills
Proficient in MS Office (Word, Excel, Outlook, etc.)
Additional Information 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.
Removal Date 30-Aug-2017