Do you enjoy a challenging learning curve?
Would you like to be involved in GMP pilot plant projects that are constantly industrializing new technologies?
This may be the job for you!
This Validation Engineer will support all aspects of validation including developing testing protocols, supporting primary field execution activities, and developing validation reports.
You will also support the development of Validation Lifecycle documents including but not limited to Validation Plans, Impact Assessments, and Validation Reports.
This Validation Engineer role will provide a hands-on, leadership role as it pertains to Biopharm Product Development & Supply, GMP Operations facility and equipment validation projects>
• Develops and executes Validation and Qualification Protocols for mechanical equipment, automated equipment/systems and utilities with minimal supervision.
• Authors Validation and Qualification Reports summarizing the results of protocol field execution activities with minimal supervision.
• Supports troubleshooting of equipment and system as needed to respond to unsuccessful validation testing.
• Interface with staff in Manufacturing Operations, Technical Services, Project Engineering, Pilot Plant Services, and Quality Assurance, as well as others, to coordinate resources/materials and complete validation activities in a timely manner.
• Perform validation activities associated with change controls and the validation maintenance program; example performance sterilization verification or periodic validation reviews.
• Attends regular safety and GMP training.
• Maintains accurate and complete safety and GMP records consistent with company policy and legal requirements.
• Recognizes potential safety and compliance problems and takes action to rectify them.
• Maintains validation equipment and instrumentation in accordance with company policy requirements.
• Writes investigation reports and updates procedures with minimal supervision.
• Bachelor of Science degree in Life Science from an accredited university.
• At least 1 year relevant validation experience.
• Knowledge of and exposure to GMP requirements, SOP's and policies.
• Basic knowledge of and exposure to regulatory requirements.
• Bachelor of Science degree in Engineering from an accredited university.
• Experience or relevant knowledge of BioPharmaceutical manufacturing desired with preference in downstream manufacturing equipment and system automated controls/instrumentation.
• Experience or relevant knowledge with PMP practices for managing projects desired
• Strong interpersonal and organizational skills.
• Strong written and verbal communication skills.
• Must be able to interact well with peers and supervisors/managers in multidisciplinary teams involving scientific, engineering, and operational disciplines.
• Ability to work on multiple projects, ability to focus on the important projects, and the flexibility to adapt to changing priorities.
• Quality and detail oriented.
• Demonstrated computer skills and experience using Microsoft Office 365 required.
• Can learn and apply new testing techniques
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
We want to help people do more, feel better, live longer
We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
Across the US, we employ more than 15,000 people who strive to help others do more, feel better and live longer. This work starts one person, one community, and one story at a time.
As a science-led, global healthcare business with clear values, we offer countless opportunities for people at various stages of their careers. On-the-job learning and rewarding individual contributions are extremely important to us. We believe in creating an inclusive and safe working environment and supporting our employees to help their communities.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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